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The Cochrane Database of Systematic... Aug 2017Maternal hypotension is the most frequent complication of spinal anaesthesia for caesarean section. It can be associated with nausea or vomiting and may pose serious... (Review)
Review
BACKGROUND
Maternal hypotension is the most frequent complication of spinal anaesthesia for caesarean section. It can be associated with nausea or vomiting and may pose serious risks to the mother (unconsciousness, pulmonary aspiration) and baby (hypoxia, acidosis, neurological injury).
OBJECTIVES
To assess the effects of prophylactic interventions for hypotension following spinal anaesthesia for caesarean section.
SEARCH METHODS
We searched Cochrane Pregnancy and Childbirth's Trials Register (9 August 2016) and reference lists of retrieved studies.
SELECTION CRITERIA
Randomised controlled trials, including full texts and abstracts, comparing interventions to prevent hypotension with placebo or alternative treatment in women having spinal anaesthesia for caesarean section. We excluded studies if hypotension was not an outcome measure.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed study quality and extracted data from eligible studies. We report 'Summary of findings' tables using GRADE.
MAIN RESULTS
We included 126 studies involving 9565 participants. Interventions were to prevent maternal hypotension following spinal anaesthesia only, and we excluded any interventions considered active treatment. All the included studies reported the review's primary outcome. Across 49 comparisons, we identified three intervention groups: intravenous fluids, pharmacological interventions, and physical interventions. Authors reported no serious adverse effects with any of the interventions investigated. Most trials reported hypotension requiring intervention and Apgar score of less than 8 at five minutes as the only outcomes. None of the trials included in the comparisons we describe reported admission to neonatal intensive care unit. Crystalloid versus control (no fluids)Fewer women experienced hypotension in the crystalloid group compared with no fluids (average risk ratio (RR) 0.84, 95% confidence interval (CI) 0.72 to 0.98; 370 women; 5 studies; low-quality evidence). There was no clear difference between groups in numbers of women with nausea and vomiting (average RR 0.19, 95% CI 0.01 to 3.91; 1 study; 69 women; very low-quality evidence). No baby had an Apgar score of less than 8 at five minutes in either group (60 babies, low-quality evidence). Colloid versus crystalloidFewer women experienced hypotension in the colloid group compared with the crystalloid group (average RR 0.68, 95% CI 0.58 to 0.80; 2105 women; 28 studies; very low-quality evidence). There were no clear differences between groups for maternal hypertension requiring intervention (average RR 0.64, 95% CI 0.09 to 4.46, 3 studies, 327 women;very low-quality evidence), maternal bradycardia requiring intervention (average RR 0.99, 95% CI 0.55 to 1.79, 6 studies, 509 women; very low-quality evidence), nausea and/or vomiting (average RR 0.83, 95% CI 0.61 to 1.13, 15 studies, 1154 women, I² = 37%; very low-quality evidence), neonatal acidosis (average RR 0.83, 95% CI 0.15 to 4.52, 6 studies, 678 babies; very low-quality evidence), or Apgar score of less than 8 at five minutes (average RR 0.24, 95% CI 0.03 to 2.05, 11 studies, 826 babies; very low-quality evidence). Ephedrine versus phenylephrineThere were no clear differences between ephedrine and phenylephrine groups for preventing maternal hypotension (average RR 0.92, 95% CI 0.71 to 1.18; 401 women; 8 studies; very low-quality evidence) or hypertension (average RR 1.72, 95% CI 0.71 to 4.16, 2 studies, 118 women, low-quality evidence). Rates of bradycardia were lower in the ephedrine group (average RR 0.37, 95% CI 0.21 to 0.64, 5 studies, 304 women, low-quality evidence). There was no clear difference in the number of women with nausea and/or vomiting (average RR 0.76, 95% CI 0.39 to 1.49, 4 studies, 204 women, I² = 37%, very low-quality evidence), or babies with neonatal acidosis (average RR 0.89, 95% CI 0.07 to 12.00, 3 studies, 175 babies, low-quality evidence). No baby had an Apgar score of less than 8 at five minutes in either group (321 babies; low-quality evidence). Ondansetron versus controlOndansetron administration was more effective than control (placebo saline) for preventing hypotension requiring treatment (average RR 0.67, 95% CI 0.54 to 0.83; 740 women, 8 studies, low-quality evidence), bradycardia requiring treatment (average RR 0.49, 95% CI 0.28 to 0.87; 740 women, 8 studies, low-quality evidence), and nausea and/or vomiting (average RR 0.35, 95% CI 0.24 to 0.51; 653 women, 7 studies, low-quality evidence). There was no clear difference between the groups in rates of neonatal acidosis (average RR 0.48, 95% CI 0.05 to 5.09; 134 babies; 2 studies, low-quality evidence) or Apgar scores of less than 8 at five minutes (284 babies, low-quality evidence). Lower limb compression versus controlLower limb compression was more effective than control for preventing hypotension (average RR 0.61, 95% CI 0.47 to 0.78, 11 studies, 705 women, I² = 65%, very low-quality evidence). There was no clear difference between the groups in rates of bradycardia (RR 0.63, 95% CI 0.11 to 3.56, 1 study, 74 women, very low-quality evidence) or nausea and/or vomiting (average RR 0.42 , 95% CI 0.14 to 1.27, 4 studies, 276 women, I² = 32%, very-low quality evidence). No baby had an Apgar score of less than 8 at five minutes in either group (130 babies, very low-quality evidence). Walking versus lyingThere was no clear difference between the groups for women with hypotension requiring treatment (RR 0.71, 95% CI 0.41 to 1.21, 1 study, 37 women, very low-quality evidence).Many included studies reported little to no information that would allow an assessment of their risk of bias, limiting our ability to draw meaningful conclusions. GRADE assessments of the quality of evidence ranged from very low to low. We downgraded evidence for limitations in study design, imprecision, and indirectness; most studies assessed only women scheduled for elective caesarean sections.External validity also needs consideration. Readers should question the use of colloids in this context given the serious potential side effects such as allergy and renal failure associated with their administration.
AUTHORS' CONCLUSIONS
While interventions such as crystalloids, colloids, ephedrine, phenylephrine, ondansetron, or lower leg compression can reduce the incidence of hypotension, none have been shown to eliminate the need to treat maternal hypotension in some women. We cannot draw any conclusions regarding rare adverse effects associated with use of the interventions (for example colloids) due to the relatively small numbers of women studied.
PubMed: 28976555
DOI: 10.1002/14651858.CD002251.pub3 -
The Cochrane Database of Systematic... Apr 2020Sickle cell disease comprises a group of genetic haemoglobin disorders. The predominant symptom associated with sickle cell disease is pain resulting from the occlusion... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Sickle cell disease comprises a group of genetic haemoglobin disorders. The predominant symptom associated with sickle cell disease is pain resulting from the occlusion of small blood vessels by abnormally 'sickle-shaped' red blood cells. There are other complications, including chronic organ damage and prolonged painful erection of the penis, known as priapism. Severity of sickle cell disease is variable, and treatment is usually symptomatic. Priapism affects up to half of all men with sickle cell disease, however, there is no consistency in treatment. We therefore need to know the best way of treating this complication in order to offer an effective interventional approach to all affected individuals. This is an update of a previously published review.
OBJECTIVES
To assess the benefits and risks of different treatments for stuttering (repeated short episodes) and fulminant (lasting for six hours or more) priapism in sickle cell disease.
SEARCH METHODS
We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Haemoglobinopathies Trials Register, which comprises references identified from comprehensive electronic database searches and handsearches of relevant journals and abstract books of conference proceedings. We also searched trial registries. Date of the most recent search of the Group's Haemoglobinopathies Trials Register: 09 September 2019. Date of most recent search of trial registries and of Embase: 01 October 2019.
SELECTION CRITERIA
All randomised or quasi-randomised controlled trials comparing non-surgical or surgical treatment with placebo or no treatment, or with another intervention for stuttering or fulminant priapism.
DATA COLLECTION AND ANALYSIS
The authors independently extracted data and assessed the risk of bias of the trials.
MAIN RESULTS
Three trials with 102 participants were identified and met the criteria for inclusion in this review. These trials compared stilboestrol to placebo, sildenafil to placebo and a four-arm trial which compared ephedrine or etilefrine to placebo and ranged in duration from two weeks to six months. All of the trials were conducted in an outpatient setting in Jamaica, Nigeria and the UK. None of the trials measured our first primary outcome, detumescence. However, all three trials reported on the reduction in frequency of stuttering priapism, our second primary outcome; and from the evidence included in this review, we are uncertain whether stilboestrol, etilefrine or ephedrine reduce the frequency of stuttering priapism as the certainty of the evidence has been assessed as very low. Additionally, we conclude that sildenafil may make little or no difference (low-certainty evidence). Two trials reported on immediate side effects and we are uncertain whether etilefrine or ephedrine reduce the occurrence of these (very low-certainty of evidence) and also conclude that sildenafil may make little or no difference in side effects (low-quality evidence). Given that all of the trials were at risk of bias and all had low participant numbers, we considered the certainty of the evidence to be low to very low.
AUTHORS' CONCLUSIONS
There is a lack of evidence for the benefits or risks of the different treatments for both stuttering and fulminant priapism in sickle cell disease. This systematic review has clearly identified the need for well-designed, adequately-powered, multicentre randomised controlled trials assessing the effectiveness of specific interventions for priapism in sickle cell disease.
Topics: Adrenergic Agents; Anemia, Sickle Cell; Diethylstilbestrol; Ephedrine; Estrogens, Non-Steroidal; Etilefrine; Humans; Male; Priapism; Randomized Controlled Trials as Topic; Sildenafil Citrate; Tachycardia; Vasoconstrictor Agents; Young Adult
PubMed: 32251534
DOI: 10.1002/14651858.CD004198.pub4 -
The Cochrane Database of Systematic... Feb 2017Topical local anaesthetics provide effective analgesia for patients undergoing numerous superficial procedures, including repair of dermal lacerations. The need for... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Topical local anaesthetics provide effective analgesia for patients undergoing numerous superficial procedures, including repair of dermal lacerations. The need for cocaine in topical anaesthetic formulations has been questioned because of concern about adverse effects, thus novel preparations of cocaine-free anaesthetics have been developed. This review was originally published in 2011 and has been updated in 2017.
OBJECTIVES
To assess whether benefits of non-invasive topical anaesthetic application occur at the expense of decreased analgesic efficacy. To compare the efficacy of various single-component or multi-component topical anaesthetic agents for repair of dermal lacerations. To determine the clinical necessity for topical application of the ester anaesthetic, cocaine.
SEARCH METHODS
For this updated review, we searched the following databases: Cochrane Central Register of Controlled Trials (CENTRAL; 2016, Issue 11), Cumulative Index to Nursing and Allied Health Literature (CINAHL; 2010 to December 2016), Embase (2010 to December 2016) and MEDLINE (2010 to December 2016). We did not limit this search by language or format of publication. We contacted manufacturers, international scientific societies and researchers in the field. Weemailed selected journalsand reviewed meta-registers of ongoing trials. For the previous version of this review, we searched these databases to November 2010.
SELECTION CRITERIA
We included randomized controlled trials (RCTs) that evaluated the efficacy and safety of topical anaesthetics for repair of dermal laceration in adult and paediatric participants.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed trial quality and extracted data. We contacted study authors for additional information when needed. We collected adverse event information from trial reports. We assessed methodological risk of bias for each included study and employed the GRADE approach to assess the overall quality of the evidence.
MAIN RESULTS
The present updated review included 25 RCTs involving 3278 participants. The small number of trials in each comparison group and the heterogeneity of outcome measures precluded quantitative analysis of data for all but one outcome: pain intensity. In two pooled studies, the mean self-reported visual analogue scale (VAS; 0 to 100 mm) score for topical prilocaine-phenylephrine (PP) was higher than the mean self-reported VAS (0 to 100 mm) score for topical tetracaine-epinephrine-cocaine (TAC) by 5.59 points (95% confidence interval (CI) 2.16 to 13.35). Most trials that compared infiltrated and topical anaesthetics were at high risk of bias, which is likely to have affected their results. Researchers found that several cocaine-free topical anaesthetics provided effective analgesic efficacy. However, data regarding the efficacy of each topical agent are based mostly on single comparisons in trials with unclear or high risk of bias. Mild, self-limited erythematous skin induration occurred in one of 1042 participants who had undergone application of TAC. Investigators reported no serious complications among any of the participants treated with cocaine-based or cocaine-free topical anaesthetics. The overall quality of the evidence according to the GRADE system is low owing to limitations in design and implementation, imprecision of results and high probability of publication bias (selective reporting of data). Additional well-designed RCTs with low risk of bias are necessary before definitive conclusions can be reached.
AUTHORS' CONCLUSIONS
We have found two new studies published since the last version of this review was prepared. We have added these studies to those previously included and have conducted an updated analysis, which resulted in the same review conclusions as were presented previously.Mostly descriptive analysis indicates that topical anaesthetics may offer an efficacious, non-invasive means of providing analgesia before suturing of dermal lacerations. Use of cocaine-based topical anaesthetics might be hard to justify, given the availability of other effective topical anaesthetics without cocaine. However, the overall quality of the evidence according to the GRADE system is low owing to limitations in design and implementation, imprecision of results and high probability of publication bias (selective reporting of data). Additional well-designed RCTs with low risk of bias are necessary before definitive conclusions can be reached.
Topics: Adult; Anesthetics, Local; Child; Cocaine; Drug Combinations; Epinephrine; Humans; Lacerations; Pain Measurement; Randomized Controlled Trials as Topic; Skin; Sutures; Tetracaine
PubMed: 28230244
DOI: 10.1002/14651858.CD005364.pub3 -
CNS Neuroscience & Therapeutics Jul 2012A systematic literature review comparing the efficacy of ephedrine and phenylephrine for the management of spinal anesthesia-induced hypotension during Cesarean sections... (Comparative Study)
Comparative Study Meta-Analysis
AIMS
A systematic literature review comparing the efficacy of ephedrine and phenylephrine for the management of spinal anesthesia-induced hypotension during Cesarean sections (C-sections) was published in 2002. A number of well-designed trials with controversial results have been published afterward. Therefore, an updated meta-analysis was necessary.
METHODS
The MEDLINE, EMBASE, and the Cochrane Library databases were searched (last search performed on September 26, 2011). Pooled risk ratio (RR) or standard mean difference (SMD) and their 95% confidence intervals (95% CI) were calculated for the incidence of intra-operative hypotension or umbilical blood pH values.
RESULTS
A total number of 15 trials and 742 parturients under elective C-sections were analyzed. When used to prevent hypotension, patients receiving ephedrine and phenylephrine did not differ significantly in the incidence of hypotension (RR = 1.22; 95% CI, 0.83-1.80), umbilical arterial pH values (SMD = -0.38; 95% CI, -1.67 to 0.92) or venous pH values (SMD = -0.18; 95% CI, -0.44 to 0.07). And administration routes did not affect the incidence of hypotension and umbilical blood pH values. When used to treat hypotension, patients given ephedrine and phenylephrine had comparable incidence of intra-operative hypotension (RR = 0.79; 95% CI, 0.40-1.56), while parturients receiving phenylephrine had neonates with higher umbilical arterial pH values (SMD = -1.32; 95% CI, -2.35 to -0.30) and venous pH values (SMD = -0.79; 95% CI, -1.09 to -0.49) than those given ephedrine.
CONCLUSION
Prophylactic use of ephedrine and phenylephrine were both effective in preventing maternal hypotension during C-section under spinal anesthesia; phenylephrine was superior to ephedrine in treating hypotension, evidenced by higher umbilical blood pH values.
Topics: Anesthesia, Spinal; Cesarean Section; Disease Management; Ephedrine; Female; Humans; Hypotension; Phenylephrine; Pregnancy
PubMed: 22759268
DOI: 10.1111/j.1755-5949.2012.00345.x -
International Journal of Obstetric... Nov 2015A range of strategies including physical interventions, intravenous fluids and vasopressor drugs have been used to minimize or prevent spinal anesthesia-induced... (Meta-Analysis)
Meta-Analysis
BACKGROUND
A range of strategies including physical interventions, intravenous fluids and vasopressor drugs have been used to minimize or prevent spinal anesthesia-induced hypotension. Recent studies suggest that ondansetron, a commonly used antiemetic, also affects hypotension. This systematic review investigated the effects of prophylactic ondansetron on hemodynamic changes following spinal anesthesia.
METHODS
Medline, Embase, Cochrane Library databases and www.clinicaltrials.gov were searched for randomized controlled trials studying the effects of ondansetron on hemodynamic changes induced by spinal anesthesia. The primary outcome was hypotension. Relative risk (RR) or mean difference, with 95% confidence intervals (CI), were used to analyze outcomes.
RESULTS
Ten randomized controlled trials with 863 patients were included in the analysis. Prophylactic ondansetron reduced the incidence of spinal anesthesia-induced hypotension in both obstetric and non-obstetric patients. The RR of spinal anesthesia-induced hypotension after ondansetron administration was 0.53 (95% CI 0.32 to 0.86) in obstetric patients and 0.16 (95% CI 0.05 to 0.51) in non-obstetric patients. There was significant heterogeneity among obstetric studies (I(2) = 71%). Ondansetron also reduced the incidence of bradycardia, nausea and vomiting after spinal anesthesia with RRs of 0.27 (95% CI 0.16 to 0.47), 0.24 (95% CI 0.14 to 0.42) and 0.48 (95% CI 0.08 to 3.08), respectively. The doses of ephedrine and phenylephrine required to treat hypotension were reduced by ondansetron with mean differences of -2.35 mg (95% CI -4.14 to -0.55 mg) and -31.16 μg (95% CI -57.46 to -4.87 μg), respectively.
CONCLUSION
This review suggests that prophylactic ondansetron reduces the incidence of spinal anesthesia-induced hypotension and vasopressor consumption in both obstetric and non-obstetric patients. In addition, ondansetron can also reduce related adverse outcomes such as bradycardia, nausea and vomiting. However, given the relatively large heterogeneity and small sample sizes in current studies, further large and strict randomized clinical trials investigating the effects of ondansetron on spinal anesthesia-induced hemodynamic changes and side effects are still needed, especially among obstetric patients.
Topics: Anesthesia, Spinal; Humans; Hypotension; Ondansetron; Serotonin Antagonists
PubMed: 26421701
DOI: 10.1016/j.ijoa.2015.08.012 -
The Cochrane Database of Systematic... 2003Faecal incontinence is a common symptom which causes significant distress and reduction in quality of life. Available treatment options for faecal incontinence include... (Review)
Review
BACKGROUND
Faecal incontinence is a common symptom which causes significant distress and reduction in quality of life. Available treatment options for faecal incontinence include conservative treatments (biofeedback, pelvic floor muscle training, dietary manipulation or drug therapy) or surgical treatments (e.g. sphincter repair, post anal repair, neosphincter). Drug treatment is often given either alone or in combination with other treatment modalities.
OBJECTIVES
To assess the effects of drug therapy for the treatment of faecal incontinence. In particular, to assess the effects of individual drugs relative to placebo or other drugs, and to compare drug therapy with other treatment modalities.
SEARCH STRATEGY
We searched the Cochrane Incontinence Group trials register (January 2003) and the reference lists of relevant articles. Date of the most recent search: January 2003.
SELECTION CRITERIA
All randomised or quasi-randomised controlled trials of the use of pharmacological agents for the treatment of faecal incontinence in adults.
DATA COLLECTION AND ANALYSIS
Working independently, reviewers selected studies from the literature, assessed the methodological quality of each trial, and extracted data.
MAIN RESULTS
Eleven trials were identified for inclusion in this review. Nine trials were of cross-over design. Seven trials included only people with faecal incontinence related to liquid stool (either chronic diarrhoea or following ileoanal pouch surgery). Three trials (total 58 participants) compared topical phenylephrine gel with placebo. Two trials (56 participants) compared loperamide with placebo. One trial (11 participants) compared loperamide oxide with placebo. One trial (15 participants) compared diphenoxylate plus atropine with placebo. One trial (17 participants) compared sodium valproate with placebo. One trial (30 participants) compared loperamide with codeine with diphenoxylate plus atropine. Two further trials (total 265 participants) assessed the use of lactulose in elderly people.No studies comparing drugs with other treatment modalities were identified. There was limited evidence that antidiarrhoeal drugs and drugs which enhance anal sphincter tone may reduce faecal incontinence in patients with liquid stools. However, the trials were small and of short duration.
REVIEWER'S CONCLUSIONS
The small number of trials identified for this review assessed several different drugs in a variety of patient populations. The focus of most of the included trials was on the treatment of diarrhoea, rather than faecal incontinence. There is little evidence to guide clinicians in the selection of drug therapies for faecal incontinence. Larger, well-designed controlled trials, which include clinically important outcome measures, are required.
Topics: Adult; Diarrhea; Fecal Incontinence; Humans; Randomized Controlled Trials as Topic
PubMed: 12917921
DOI: 10.1002/14651858.CD002116 -
The Cochrane Database of Systematic... Dec 2018Epistaxis (nosebleed) most commonly affects children and the elderly. The majority of episodes are managed at home with simple measures. In more severe cases medical... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Epistaxis (nosebleed) most commonly affects children and the elderly. The majority of episodes are managed at home with simple measures. In more severe cases medical intervention is required to either cauterise the bleeding vessel, or to pack the nose with various materials. Tranexamic acid is used in a number of clinical settings to stop bleeding by preventing clot breakdown (fibrinolysis). It may have a role in the management of epistaxis as an adjunct to standard treatments, reducing the need for further intervention.
OBJECTIVES
To determine the effects of tranexamic acid (oral, intravenous or topical) compared with placebo, no additional intervention or any other haemostatic agent in the management of patients with epistaxis.
SEARCH METHODS
The Cochrane ENT Information Specialist searched the Cochrane ENT Register (via CRS Web); Central Register of Controlled Trials (CENTRAL) (via CRS Web); PubMed; Ovid Embase; CINAHL; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 29 October 2018.
SELECTION CRITERIA
Randomised controlled trials (RCTs) of tranexamic acid (in addition to usual care) compared with usual care plus placebo, usual care alone or usual care plus any other haemostatic agent, to control epistaxis in adults or children.
DATA COLLECTION AND ANALYSIS
We used the standard methodological procedures expected by Cochrane. The primary outcomes were control of epistaxis: re-bleeding (as measured by the proportion of patients re-bleeding within a period of up to 10 days) and significant adverse effects (seizures, thromboembolic events). Secondary outcomes were control of epistaxis as measured by the time to stop initial bleeding (the proportion of patients whose bleeding is controlled within a period of up to 30 minutes); severity of re-bleeding (as measured by (a) the proportion of patients requiring any further intervention and (b) the proportion of patients requiring blood transfusion); length of hospital stay and other adverse effects. We used GRADE to assess the quality of the evidence for each outcome; this is indicated in italics.
MAIN RESULTS
We included six RCTs (692 participants). The overall risk of bias in the studies was low. Two studies assessed oral administration of tranexamic acid, given regularly over several days, and compared it to placebo. In the other four studies, a single application of topical tranexamic acid was compared with placebo (one study) and a combination of epinephrine and lidocaine or phenylephrine (three studies). All participants were adults.Tranexamic acid versus placeboFor our primary outcome, control of epistaxis: re-bleeding (proportion re-bleeding within 10 days), we were able to pool data from three studies. The pooled result demonstrated a benefit of tranexamic acid compared to placebo, the risk of re-bleeding reducing from 67% to 47% (risk ratio (RR) 0.71, 95% confidence interval (CI) 0.56 to 0.90; three studies; 225 participants; moderate-quality evidence).When we compared the effects of oral and topical tranexamic acid separately the risk of re-bleeding with oral tranexamic acid reduced from 69% to 49%, RR 0.73 (95% CI 0.55 to 0.96; two studies, 157 participants; moderate-quality evidence) and with topical tranexamic acid it reduced from 66% to 43%, RR 0.66 (95% CI 0.41 to 1.05; single study, 68 participants). We rated the quality of evidence provided by the single study as low, therefore it is uncertain whether topical tranexamic acid is effective in stopping bleeding in the 10-day period after a single application.No study specifically sought to identify and report our primary outcome: significant adverse effects (i.e. seizures, thromboembolic events).The secondary outcome time to stop initial bleeding (proportion with bleeding controlled within 30 minutes) was measured in one study using topical tranexamic acid and there was no evidence of a difference at 30 minutes (RR 0.79, 95% CI 0.56 to 1.11; 68 participants; low-quality evidence).No studies reported the proportion of patients requiring any further intervention (e.g. repacking, surgery, embolisation).One study of oral tranexamic acid reported the proportion of patients requiring blood transfusion and found no difference between groups: 5/45 (11%) versus 6/44 (14%) (RR 0.81, 95% CI 0.27 to 2.48; 89 participants; low-quality evidence).Two studies reported hospital length of stay. One study reported a significantly shorter stay in the oral tranexamic acid group (mean difference (MD) -1.60 days, 95% CI -2.49 to -0.71; 68 participants). The other study found no evidence of a difference between the groups.Tranexamic acid versus other haemostatic agentsWhen we pooled the data from three studies the proportion of patients whose bleeding stopped within 10 minutes was significantly higher in the topical tranexamic acid group compared to the group receiving another haemostatic agent (70% versus 30%: RR 2.35, 95% CI 1.90 to 2.92; 460 participants) (moderate-quality evidence).Adverse effects across all studiesFive studies recorded 'adverse effects' in a general way. None found any difference between the groups in the occurrence of minor adverse effects (e.g. mild nausea and diarrhoea, 'bad taste' of gel). In one study a patient developed a superficial thrombophlebitis of both legs following discharge, however it is not reported in which group this occurred. No "other serious adverse effect" was reported in any study.
AUTHORS' CONCLUSIONS
We found moderate-quality evidence that there is probably a reduction in the risk of re-bleeding with the use of either oral or topical tranexamic acid in addition to usual care in adult patients with epistaxis, compared to placebo with usual care. However, the quality of evidence relating solely to topical tranexamic acid was low (one study only), so we are uncertain whether or not topical tranexamic acid is effective in stopping bleeding in the 10-day period after a single application. We found moderate-quality evidence that topical tranexamic acid is probably better than other topical agents in stopping bleeding in the first 10 minutes.There have been only three RCTs on this subject since 1995. Since then there have been significant changes in nasal cauterisation and packing techniques (for example, techniques including nasal endoscopy and more invasive approaches such as endoscopic sphenopalatine artery ligation). New trials would inform us about the effectiveness of tranexamic acid in light of these developments.
Topics: Administration, Oral; Administration, Topical; Antifibrinolytic Agents; Blood Transfusion; Epinephrine; Epistaxis; Humans; Length of Stay; Lidocaine; Phenylephrine; Placebos; Randomized Controlled Trials as Topic; Recurrence; Secondary Prevention; Tranexamic Acid
PubMed: 30596479
DOI: 10.1002/14651858.CD004328.pub3 -
JBI Library of Systematic Reviews 2010Inadvertent hypothermia is common in patient's undergoing surgical procedures. Hypothermia within the perioperative environment may have many undesired physiological...
BACKGROUND
Inadvertent hypothermia is common in patient's undergoing surgical procedures. Hypothermia within the perioperative environment may have many undesired physiological effects that are associated with significant postoperative morbidity. Patient's temperature drops to below 35°C during the first hour of anaesthesia because of impaired thermoregulatory mechanism and patient getting cold in the operating theatre. For this reason, health care professionals working in the perioperative environment need to know what are the most effective strategies for treating or preventing hypothermia to improving patient outcomes following surgical procedures. However, to date there has been no systematic review of effectiveness with high quality randomised controlled trials to identify effective strategies for the prevention and/or management of hypothermia in the perioperative environment.
OBJECTIVE
The objective of this systematic review was to identify the most effective strategies for the prevention and/or management of hypothermia in the intraoperative and postoperative phases of surgical care.
DATA SOURCES
A comprehensive search was undertaken on electronic databases from their inception to October 2008, including Cochrane library, MEDLINE, PubMed, CENTRAL, CINAHL, Current contents connect, DARE, Dissertations Abstract International, EMBASE, Scopus, and TRIP. The search was restricted to English language.
REVIEW METHODS
Randomised controlled trials or clinical controlled trials were sought, which evaluated the effectiveness of active or passive warming techniques in the prevention and/or treatment of inadvertent hypothermia. Critical appraisal of study quality was undertaken using Joanna Briggs Institute critical appraisal instruments. Data extraction was via the Joanna Briggs Institute standard data extraction form for evidence of effectiveness.
RESULTS
Eighteen studies with a combined 1451 patients were included. The results were classified into three categories with a further sub classification within the active warming techniques category.Forced air warming was effective in maintaining intraoperative normothermia when compared to passive warming, routine thermal care and no form of warming. Forced air warming in pregnant women scheduled for caesarean delivery under regional anaesthesia prevented maternal and foetal hypothermia. In contrast, passive warming with tight elastic bandages wrapped around the legs (passive insulation) in the same patient population had no significant benefits in preventing maternal hypothermia.However, in arthroscopic knee surgery patients, forced air warming did not result in a decrease in the incidence of postoperative shivering indicating that it was not effective or feasible to extend active warming into recovery in this patient population. Forced air warming was effective than circulating water mattress in preventing hypothermia in patients who underwent repair of infrarenal aortic aneurysms. Forced air warming was effective against radiant warming in maintaining intraoperative normothermia in lengthier surgical procedures.Prewarming in different patient populations prevents redistribution hypothermia, especially after one hour of anaesthesia induction. Intravenous and irrigating fluids warmed (38-40°C) to a temperature higher than that of room temperature by different fluid warming devices (both dry and water heated) proved significantly beneficial to patients in terms of stable haemodynamic variables, and higher core temperature (core T) at the end of the surgery (transurethral prostatectomy and orthopaedic surgery). However, prewarming irrigation fluids in knee arthroscopy patients did not prove beneficial in maintaining normothermia.Water garment warmer was significantly (P < 0.05) effective than forced air warming in maintaining intraoperative normothermia in orthotopic liver transplantation patients. Extra warming with forced air compared to routine thermal care was effective in reducing the incidence of surgical wound infections and postoperative cardiac complications, as well as shorten the length of hospital stay.Passive warming with reflective heating blankets or elastic bandages wrapped around the legs tightly were found to be ineffective in reducing the incidence or magnitude of hypothermia. Low-flow anaesthesia with active forced air warming was effective in stabilising patient's core T during surgical procedures when compared to low-flow anaesthesia alone or low-flow anaesthesia with passive insulation.Phenylephrine i.v. infusion resulted in a significantly less reduction in core T after first hour of anaesthesia and patients were warmer until the end of the surgery (minor oral surgery).
CONCLUSION
Active warming with forced air warming units keeps all patients warmer in the intraoperative and postoperative periods. Forced air warming compared with alternate forms of warming reduces the incidence of shivering and wound infections, increases thermal comfort and reduces morbid cardiac events.
IMPLICATIONS FOR PRACTICE
Our review indicates that active warming techniques (forced-air warming) are effective in preventing and managing hypothermia in the perioperative environment and based on the results from the review there are several recommendations to guide clinical practice: IMPLICATIONS FOR RESEARCH: Future research should focus on large, high quality randomised controlled trials looking at long-term clinical outcomes, operating temperature forced-air warming devices (not just maximum set temperature), different body sites and percentage of body coverage area of active warming for efficient management of intraoperative hypothermia.
PubMed: 27820534
DOI: 10.11124/01938924-201008190-00001