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The American Journal of Emergency... Jan 2022The most common presenting complaint to the emergency department (ED) is pain. Several studies have shown that a large proportion of ED patients either receive no or...
BACKGROUND
The most common presenting complaint to the emergency department (ED) is pain. Several studies have shown that a large proportion of ED patients either receive no or sub-optimal analgesia. Patient-controlled analgesia (PCA) pumps used in the post-operative setting has shown to decrease total opioid consumption and has increased patient and nurse satisfaction.
OBJECTIVE
The purpose of this systematic review was to evaluate clinical trials that have used PCAs in the ED setting, to evaluate safety and efficacy as well as patient and healthcare provider experience.
METHODS
A search of PubMed, MEDLINE, and the Cochrane Database was conducted using the MESH search terms emergency department, patient-controlled analgesia, and acute pain up to September 2021. These terms were searched in all fields of publication and were limited to the English-language articles, clinical "human" studies, and studies that included the use of patient-controlled analgesia in the setting of the emergency department.
RESULTS
The search initially identified 227 potentially relevant articles and a total of 10 studies met criteria for inclusion. ED use of PCA therapy was associated with increased patient satisfaction, decreased pain scores, and an overall increase in opioid consumption.
CONCLUSION
The quality, the differences in study methods and outcome measures used, and heterogeneity of the studies performed to date do not provide adequate evidence to support its widespread use in the ED. Well-designed studies conducted in the ED are still needed to evaluate the ideal patient population to whom these PCAs may provide the most benefit as well as a robust cost-analysis to ensure feasibility of use in the future.
Topics: Acute Pain; Analgesia, Patient-Controlled; Analgesics, Opioid; Costs and Cost Analysis; Emergency Service, Hospital; Humans; Pain, Postoperative; Patient Satisfaction; Randomized Controlled Trials as Topic
PubMed: 34775197
DOI: 10.1016/j.ajem.2021.10.042 -
JBI Evidence Synthesis Jan 2022The aim of this systematic review was to determine the safety and effectiveness of parent- or nurse-controlled analgesia on neonatal patient outcomes. More specifically,...
OBJECTIVE
The aim of this systematic review was to determine the safety and effectiveness of parent- or nurse-controlled analgesia on neonatal patient outcomes. More specifically, the objective was to determine the effect of parent- or nurse-controlled analgesia on neonatal pain scores, analgesic use, and incidence of iatrogenic withdrawal syndrome, as well as any opioid-associated adverse events.
INTRODUCTION
Despite recent innovations in neonatology leading to significant improvements in short- and long-term outcomes for newborns requiring intensive care, optimal management of pain and distress remains a challenge for the multidisciplinary treatment team. The inability of neonates to communicate pain easily, inconsistent practice among health professionals, insufficient analgesic prescriptions, and delays in medical reviews all impact effective pain management. Exploring the effect of parent- or nurse-controlled analgesia may identify a modality that negates these concerns and improves the pharmacological management of pain in newborns.
INCLUSION CRITERIA
This review considered experimental and observational studies evaluating the safety and effectiveness of parent- or nurse-controlled analgesia that included babies born at 23 weeks' gestation to four weeks post-term. The interventions considered for inclusion were any type of analgesia delivered by an infusion pump that allowed bolus dosing or a continuous analgesic infusion with bolus dosing as required. Studies using algorithms and protocols to guide timing and dosage were eligible for inclusion. Comparators included the standard management of pain for neonates in the newborn intensive care unit. A modification to the a priori protocol was made to include all neonates nursed outside of a neonatal intensive care unit to ensure all studies that examined the use of parent- or nurse-controlled analgesia in the neonatal population were included in the review.
METHODS
An extensive search of six major databases was conducted (CINAHL, Cochrane Library, Embase, PubMed, PsycINFO, and Web of Science). Studies published from 1997 to 2020 in English were considered for inclusion in this review. Databases searched for unpublished studies included MedNar and ProQuest Dissertations and Theses.
RESULTS
Fourteen studies were included in this review: two randomized controlled trials, six quasi-experimental studies, one case-control study, and five case series. There was considerable heterogeneity in the interventions and study outcome measures within the studies, resulting in an inability to statistically pool results. The small sample sizes and inability to distinguish data specific to neonates in six of the studies resulted in low quality of evidence for the safety and effectiveness of parent- or nurse-controlled analgesia in neonates. However, studies reporting neonatal data demonstrated low pain scores and a trend in reduced opioid consumption when parent- or nurse-controlled analgesia was used.
CONCLUSIONS
The use of parent- or nurse-controlled analgesia in the neonatal population has shown some effect in reducing the amount of opioid analgesia required without compromising pain relief or increasing the risk of adverse events. Due to the paucity of evidence available, certainty of the results is compromised; therefore, larger trials exploring the use of parent- or nurse-controlled analgesia in neonates and the development of nurse-led models for analgesia delivery are needed.
SYSTEMATIC REVIEW REGISTRATION NUMBER
PROSPERO CRD42018114382.
Topics: Analgesia; Case-Control Studies; Female; Humans; Infant, Newborn; Labor Pain; Pain Management; Parents; Pregnancy; Randomized Controlled Trials as Topic
PubMed: 34387281
DOI: 10.11124/JBIES-20-00385 -
Medicine Jan 2022Patient-controlled analgesia (PCA) is an effective method of postoperative pain, there have been many studies performed that have compared the efficacy of hydromorphone... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Patient-controlled analgesia (PCA) is an effective method of postoperative pain, there have been many studies performed that have compared the efficacy of hydromorphone with continuous sufentanil. The purpose of this systematic review is to compare the efficacy and safety of hydromorphone and sufentanil.
METHODS
Seven databases were searched for controlled trials to compare the efficacy and safety of hydromorphone and sufentanil. After selecting the studies, extracting the data, and assessing study quality, the meta-analysis was performed on several of the studies with RevMan 5.3.
RESULTS
Thirteen studies comprised of 812 patients were found. The pain intensity of the hydromorphone group was significantly lower than that of the sufentanil group at 12 hours. With no statistical difference at 24 to 48 hours (MD12 = -1.52, 95% CI [-2.13, -1.97], P <.05). The sedation intensity of the hydromorphone group at 12, 24, and 48 hours were lower than those of the sufentanil group, with no statistical difference (MD12 = -0.03, 95% CI [-0.18, 0.12], P > .05; MD24 = -0.20, 95% CI [-0.42, 0.03], P > .05; MD48 = -0.03, 95% CI [-0.18, 0.11)], P > .05). The PCA requests in the hydromorphone group were less than that in the sufentanil group, and there was no significant difference (RR = -0.20, 95% CI [-1.93,1.53], P > .05). The incidence of adverse events in the hydromorphone group was less than that in the sufentanil group, and there was a statistical difference: (RR = 0.61, 95% CI [0.47,0.79], P < .05).
CONCLUSION
Compared with sufentanil, PCA with hydromorphone was more effective in relieving pain and PCA requests 12, 24, and 48 hours after operation, and significantly reduced the incidence of adverse events, but it did not have an advantage in sedation intensity.
Topics: Analgesia, Patient-Controlled; Analgesics, Opioid; Anesthetics, Intravenous; Humans; Hydromorphone; Narcotics; Pain, Postoperative; Sufentanil
PubMed: 35060534
DOI: 10.1097/MD.0000000000028615 -
Journal of Neurosurgical Anesthesiology Jul 2017Acupuncture treatment has been used in China for >2500 years, and at present it is used worldwide as a form of analgesia in patients with acute and chronic pain.... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Acupuncture treatment has been used in China for >2500 years, and at present it is used worldwide as a form of analgesia in patients with acute and chronic pain. Furthermore, acupuncture is regularly used not only as a single anesthetic technique but also as a supplement or in addition to general anesthesia (GA).
OBJECTIVES
The aim of this systematic review and meta-analysis was to assess the level of evidence for the clinical use of acupuncture in addition to GA in patients undergoing craniotomy.
DESIGN
This is a systematic review of randomized controlled trials with meta-analyses.
DATA SOURCES
The literature search (PubMed, Cochrane Library, and Web of Science) yielded 56 citations, published between 1972 and March 01, 2015. No systematic review or meta-analyses on this topic matched our search criteria. Each article of any language was assessed and rated for the methodological quality of the studies, using the recommendation of the Oxford Centre for Evidence Based Medicine. Ten prospective randomized controlled clinical trials with a total of 700 patients were included.
ELIGIBILITY CRITERIA
Included in the meta-analysis were studies that involved any craniotomy under GA compared with a combination of GA and acupuncture. Exclusion criteria were no acupuncture during surgery, no GA during surgery, only postoperative data available, animal studies, and low grade of evidence.
RESULTS
The use of acupuncture significantly reduced the amount of volatile anesthetics during surgery (P<0.001) and led to faster extubation time (P=0.001) and postoperative patient recovery (P=0.003). In addition, significantly reduced blood levels of the brain tissue injury marker S100β 48 hours after operation (P=0.001) and occurrence of postoperative nausea and vomiting (P=0.017) were observed. No patient studied suffered from awareness.
CONCLUSIONS
The analysis suggests that the complementary use of acupuncture for craniotomy has additional analgesic effects, reduces the needed amount of volatile anesthetic, reduces the onset of postoperative nausea and vomiting, and might have protective effects on brain tissue. Our findings may stimulate future randomized controlled trials to provide definitive recommendations.
Topics: Acupuncture Analgesia; Anesthesia; Craniotomy; Humans; Postoperative Complications
PubMed: 26967459
DOI: 10.1097/ANA.0000000000000290 -
Anesthesia and Analgesia Oct 2016Bolus administration of opioids via a patient-controlled analgesia (PCA) device is widely used in the postoperative pediatric population. PCA devices have been shown to... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Bolus administration of opioids via a patient-controlled analgesia (PCA) device is widely used in the postoperative pediatric population. PCA devices have been shown to provide superior analgesia and greater patient satisfaction compared with intermittent administration. Studies comparing the efficacy of PCA with and without a background infusion for postoperative analgesia in children vary considerably in terms of dosing and methodologic quality, making it difficult for practitioners to derive clinically useful information. The purpose of this meta-analysis was to assess whether the addition of a background infusion to PCA bolus administration of an opioid analgesic is more effective (defined as lower pain scores) than PCA bolus alone in the postoperative population specific to children.
METHODS
We searched Medline, Embase, and CENTRAL from inception to January 2015 for registered and ongoing trials included in the meta-Register of Controlled Trials and ClinicalTrials.gov, and reference lists of review articles and included articles. Study selection was randomized controlled studies comparing PCA bolus with PCA bolus plus background infusion for postoperative analgesia in children aged 0 to 18 years and adolescents aged 13 to 21 years undergoing any form of surgery that used patient-reported pain scores as an outcome measure. Two reviewers independently extracted data on patient and study characteristics, interventions, and outcomes from included studies using standardized data extraction forms. Seven trials met our eligibility criteria. Data were analyzed using Review Manager version 5.3. Meta-analyses were performed for outcomes that were defined similarly and reported in 2 or more studies, including patient-reported pain scores, nausea and/or vomiting, sedation, and opioid consumption. We independently assessed the risk of bias for each outcome and the certainty in the estimates of effect for critically important outcomes (pain scores, nausea and/or vomiting, excessive sedation) using Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology. Subgroup analyses based on dose of background infusion (high versus low dose) and risk of bias (low versus high/unclear) were performed.
RESULTS
There were no significant differences found with respect to pain scores 12 and 24 hours after surgery, opioid consumption, or risk of adverse events with the addition of a background opioid infusion to PCA opioid bolus doses. The quality of the evidence was deemed to be low to very low.
CONCLUSIONS
There was no significant difference in outcomes with the addition of an opioid background infusion to PCA bolus doses of opioid. Further high-quality studies are required.
Topics: Adolescent; Analgesia, Patient-Controlled; Analgesics, Opioid; Child; Child, Preschool; Drug Therapy, Combination; Humans; Pain, Postoperative; Randomized Controlled Trials as Topic
PubMed: 27065359
DOI: 10.1213/ANE.0000000000001244 -
The Cochrane Database of Systematic... Oct 2022Although pain is common in osteoarthritis, most people fail to achieve adequate analgesia. Increasing acknowledgement of the contribution of pain sensitisation has... (Review)
Review
BACKGROUND
Although pain is common in osteoarthritis, most people fail to achieve adequate analgesia. Increasing acknowledgement of the contribution of pain sensitisation has resulted in the investigation of medications affecting pain processing with central effects. Antidepressants contribute to pain management in other conditions where pain sensitisation is present.
OBJECTIVES
To assess the benefits and harms of antidepressants for the treatment of symptomatic knee and hip osteoarthritis in adults.
SEARCH METHODS
We used standard, extensive Cochrane search methods. The latest search was January 2021.
SELECTION CRITERIA
We included randomised controlled trials of adults with osteoarthritis that compared use of antidepressants to placebo or alternative comparator. We included trials that focused on efficacy (pain and function), treatment-related adverse effects and had documentation regarding discontinuation of participants. We excluded trials of less than six weeks of duration or had participants with concurrent mental health disorders.
DATA COLLECTION AND ANALYSIS
We used standard Cochrane methods. Major outcomes were pain; responder rate; physical function; quality of life; and proportion of participants who withdrew due to adverse events, experienced any adverse events or had serious adverse events. Minor outcomes were proportion meeting the OARSI (Osteoarthritis Research Society International) Response Criteria, radiographic joint structure changes and proportion of participants who dropped out of the study for any reason. We used GRADE to assess certainty of evidence.
MAIN RESULTS
Nine trials (2122 participants) met the inclusion criteria. Seven trials examined only knee osteoarthritis. Two also included participants with hip osteoarthritis. All trials compared antidepressants to placebo, with or without non-steroidal anti-inflammatory drugs. Trial sizes were 36 to 388 participants. Most participants were female, with mean ages of 54.5 to 65.9 years. Trial durations were 8 to 16 weeks. Six trials examined duloxetine. We combined data from nine trials in meta-analyses for knee and hip osteoarthritis. One trial was at low risk of bias in all domains. Five trials were at risk of attrition and reporting bias. High-certainty evidence found that antidepressants resulted in a clinically unimportant improvement in pain compared to placebo. Mean reduction in pain (0 to 10 scale, 0 = no pain) was 1.7 points with placebo and 2.3 points with antidepressants (mean difference (MD) -0.59, 95% confidence interval (CI) -0.88 to -0.31; 9 trials, 2122 participants). Clinical response was defined as achieving a 50% or greater reduction in 24-hour mean pain. High-certainty evidence demonstrated that 45% of participants receiving antidepressants had a clinical response compared to 28.6% receiving placebo (RR 1.55, 95% CI 1.32 to 1.82; 6 RCTs, 1904 participants). This corresponded to an absolute improvement in pain of 16% more responders with antidepressants (8.9% more to 26% more) and a number needed to treat for an additional beneficial effect (NNTB) of 6 (95% CI 4 to 11). High-certainty evidence showed that the mean improvement in function (on 0 to 100 Western Ontario and McMaster Universities Arthritis Index, 0 = best function) was 10.51 points with placebo and 16.16 points with antidepressants (MD -5.65 points, 95% CI -7.08 to -4.23; 6 RCTs, 1909 participants). This demonstrates a small, clinically unimportant response. Moderate-certainty evidence (downgraded for imprecision) showed that quality of life measured using the EuroQol 5-Dimension scale (-0.11 to 1.0, 1.0 = perfect health) improved by 0.07 points with placebo and 0.11 points with antidepressants (MD 0.04, 95% CI 0.01 to 0.07; 3 RCTs, 815 participants). This is clinically unimportant. High-certainty evidence showed that total adverse events increased in the antidepressant group (64%) compared to the placebo group (49%) (RR 1.27, 95% CI 1.15 to 1.41; 9 RCTs, 2102 participants). The number needed to treat for an additional harmful outcome (NNTH) was 7 (95% CI 5 to 11). Low-certainty evidence (downgraded twice for imprecision for very low numbers of events) found no evidence of a difference in serious adverse events between groups (RR 0.94, 95% CI 0.46 to 1.94; 9 RCTs, 2101 participants). The NNTH was 1000. Moderate-certainty evidence (downgraded for imprecision) showed that 11% of participants receiving antidepressants withdrew from trials due to an adverse event compared to 5% receiving placebo (RR 2.15, 95% CI 1.56 to 2.97; 6 RCTs, 1977 participants). The NNTH was 17 (95% CI 10 to 35).
AUTHORS' CONCLUSIONS
There is high-certainty evidence that use of antidepressants for knee osteoarthritis leads to a non-clinically important improvement in mean pain and function. However, a small number of people will have a 50% or greater important improvement in pain and function. This finding was consistent across all trials. Pain in osteoarthritis may be due to a variety of causes that differ between individuals. It may be that the cause of pain that responds to this therapy is only present in a small number of people. There is moderate-certainty evidence that antidepressants have a small positive effect on quality of life with heterogeneity between trials. High-certainty evidence indicates antidepressants result in more adverse events and moderate-certainty evidence indicates more withdrawal due to adverse events. There was little to no difference in serious adverse events (low-certainty evidence due to low numbers of events). This suggests that if antidepressants were being considered, there needs to be careful patient selection to optimise clinical benefit given the known propensity for adverse events with antidepressant use. Future trials should include alternative antidepressant agents or phenotyping of pain in people with osteoarthritis, or both.
Topics: Adult; Aged; Female; Humans; Male; Middle Aged; Anti-Inflammatory Agents, Non-Steroidal; Antidepressive Agents; Duloxetine Hydrochloride; Osteoarthritis, Hip; Osteoarthritis, Knee; Pain; Quality of Life; Randomized Controlled Trials as Topic
PubMed: 36269595
DOI: 10.1002/14651858.CD012157.pub2 -
European Journal of Obstetrics,... Aug 2023To identify which gynecologic procedures are eligible to be performed under PSA with propofol and to describe safety and effectiveness of these procedures in this... (Review)
Review
OBJECTIVE
To identify which gynecologic procedures are eligible to be performed under PSA with propofol and to describe safety and effectiveness of these procedures in this setting.
METHODS
A systematic review of the literature was conducted in Pubmed (MEDLINE), Embase and The Cochrane Library from inception until September 21st 2022. Cohort studies and randomized controlled trials were included when they reported on clinical outcomes of gynecologic procedures under procedural sedation and analgesia in which propofol was used as an anesthetic. Studies were excluded when sedation without propofol was used, when they only mentioned the use of procedural sedation and analgesia but did not describe any clinical outcome parameters or when < 10 patients were included. The primary outcome parameter was completeness of procedure. Secondary outcome parameters were type of gynecologic procedure, intraoperative complication rate, patient satisfaction, postoperative pain, duration of hospital admission, patient's discomfort and ease of procedure as judged by the surgeon. The Cochrane risk of bias tool and the ROBINS-I tool were used for bias assessment. A narrative synthesis of the findings from the included studies was provided. Numbers and percentages were presented, as well as means with standard deviations and medians with interquartile range where applicable.
RESULTS
Eight studies were included. A total of 914 patients underwent gynecologic surgical procedures with procedural sedation and analgesia with propofol. Gynecological procedures varied from hysteroscopic procedures, vaginal prolapse surgery and laparoscopic procedures. The percentage of complete procedures was 89.8%-100%. Complications occurred in 0-6.5% of patients. Other outcomes were measured in various ways, but overall patient satisfaction was high and postoperative pain was low.
CONCLUSION
The use of PSA with propofol is promising for a wide range of gynecologic procedures, including hysteroscopic procedures, vaginal prolapse surgery and laparoscopic procedures. The use of PSA with propofol seems to be effective and safe and leads to high degree of patient satisfaction. More research is needed in order to determine for which types of procedures PSA can be used.
Topics: Humans; Female; Propofol; Uterine Prolapse; Analgesia; Pain, Postoperative; Gynecologic Surgical Procedures
PubMed: 37327552
DOI: 10.1016/j.ejogrb.2023.05.035 -
Australasian Emergency Nursing Journal... May 2017Nurse-initiated medications are one of the most important strategies used to facilitate timely care for people who present to Emergency Departments (EDs). The purpose of... (Review)
Review
BACKGROUND
Nurse-initiated medications are one of the most important strategies used to facilitate timely care for people who present to Emergency Departments (EDs). The purpose of this paper was to systematically review the evidence of nurse-initiated medications to guide future practice and research.
METHODS
A systematic review of the literature was conducted to locate published studies and Grey literature. All studies were assessed independently by two independent reviewers for relevance using titles and abstracts, eligibility dictated by the inclusion criteria, and methodological quality.
RESULTS
Five experimental studies were included in this review: one randomised controlled trial and four quasi-experimental studies conducted in paediatric and adult EDs. The nurse-initiated medications were salbutamol for respiratory conditions and analgesia for painful conditions, which enabled patients to receive the medications quicker by half-an-hour compared to those who did not have nurse-initiated medications. The intervention had no effect on adverse events, doctor wait time and length of stay. Nurse-initiated analgesia was associated with increased likelihood of receiving analgesia, achieving clinically-relevant pain reduction, and better patient satisfaction.
CONCLUSION
Nurse-initiated medications are safe and beneficial for ED patients. However, randomised controlled studies are required to strengthen the validity of results.
Topics: Albuterol; Analgesics; Bronchodilator Agents; Drug Prescriptions; Emergency Nursing; Emergency Service, Hospital; Humans; Practice Patterns, Nurses'; Time Factors
PubMed: 28462830
DOI: 10.1016/j.aenj.2017.04.001 -
The Cochrane Database of Systematic... Apr 2017Multiple analgesic strategies for pain relief during labour are available. Recently remifentanil, a short-acting opioid, has recently been used as an alternative... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Multiple analgesic strategies for pain relief during labour are available. Recently remifentanil, a short-acting opioid, has recently been used as an alternative analgesic due to its unique pharmacological properties.
OBJECTIVES
To systematically assess the effectiveness of remifentanil intravenous patient-controlled analgesia (PCA) for labour pain, along with any potential harms to the mother and the newborn.
SEARCH METHODS
We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (9 December 2015), ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP), handsearched congress abstracts (November 2015), and reference lists of retrieved studies.
SELECTION CRITERIA
Randomised controlled trials (RCTs) and cluster-randomised trials comparing remifentanil (PCA) with another opioid (intravenous (IV)/intramuscular (IM)), or with another opioid (PCA), or with epidural analgesia, or with remifentanil (continuous IV), or with remifentanil (PCA, different regimen), or with inhalational analgesia, or with placebo/no treatment in all women in labour including high-risk groups with planned vaginal delivery.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed trials for inclusion, extracted data, and appraised study quality.We contacted study authors for additional information other than incomplete outcome data. We performed random-effects meta-analysis.To reduce the risk of random error in meta-analysis we performed trial sequential analysis. We included total zero event trials and used a constant continuity correction of 0.01 (ccc 0.01) for meta-analysis. We applied the Grades of Recommendation, Assessment, Development, and Evaluation (GRADE) approach to assess the quality of evidence.
MAIN RESULTS
Twenty RCTs with 3569 women were included. Of those, 10 trials (2983 participants) compared remifentanil (PCA) to an epidural, four trials (216 participants) to another opioid (IV/IM), three trials (215 participants) to another opioid (PCA), two trials (135 participants) to remifentanil (continuous IV), and one trial (20 participants) to remifentanil (PCA, different regimen). No trials were identified for the remaining comparisons.Methodological quality of studies was moderate to poor. We assessed risk of bias as high for blinding issues and incomplete outcome data in 65% and 45% of the included studies, respectively.There is evidence of effect that women in the remifentanil (PCA) group were more satisfied with pain relief than women in the other opioids (IV/IM) group (standardised mean difference (SMD) 2.11, 95% confidence interval (CI) 0.72 to 3.49, four trials, very low-quality evidence), and that women were less satisfied compared to women in the epidural group (SMD -0.22, 95% CI -0.40 to -0.04, seven trials, very low-quality evidence).There is evidence of effect that remifentanil (PCA) provided stronger pain relief at one hour than other opioids administered IV/IM (SMD -1.58, 95% CI -2.69 to -0.48, three trials, very low-quality evidence) or via PCA (SMD -0.51, 95% CI -1.01 to -0.00, three trials, very low-quality evidence). Pain intensity was higher in the remifentanil (PCA) group compared to the epidural group (SMD 0.57, 95% CI 0.31 to 0.84, six trials, low-quality evidence).Data were limited on safety aspects for both the women and the newborns. Only one study analysed maternal apnoea in a comparison of remifentanil (PCA) versus epidural and reported that half of the women in the remifentanil and none in the epidural group had an apnoea (very low-quality evidence). There is no evidence of effect that remifentanil (PCA) was associated with an increased risk for maternal respiratory depression when compared to epidural analgesia (RR 0.91, 95% CI 0.51 to 1.62, ccc 0.01, three trials, low-quality evidence) and no reliable conclusion might be reached compared to remifentanil (continuous IV) (all study arms included zero events, two trials, low-quality evidence). In one trial of remifentanil (PCA) versus another opioid (IM) three out of 18 women in the remifentanil and none out of 18 in the control group had a respiratory depression (very low-quality evidence).There is no evidence of effect that remifentanil (PCA) was associated with an increased risk for newborns with Apgar scores less than seven at five minutes compared to epidural analgesia (RR 1.26, 95% CI 0.62 to 2.57, ccc 0.01, five trials, low-quality evidence) and no reliable conclusion might be reached compared to another opioid (IV) and compared to remifentanil (PCA, different regimen) both with zero events in all study arms (one trial, very-low quality evidence). In one trial of remifentanil (PCA) versus another opioid (PCA) none out of nine newborns in the remifentanil and three out of eight in the opioid (PCA) group had Apgar scores less than seven (very-low quality evidence).There is evidence that remifentanil (PCA) was associated with a lower risk for the requirement of additional analgesia when compared to other opioids (IV/IM) (RR 0.57, 95% CI 0.40 to 0.81, three trials, moderate-quality evidence) and that it was associated with a higher risk compared to epidural analgesia (RR 9.27, 95% CI 3.73 to 23.03, ccc 0.01, six trials, moderate-quality evidence). There is no evidence of effect that remifentanil (PCA) reduced the requirement for additional analgesia compared to other opioids (PCA) (RR 0.76, 95% CI 0.45 to 1.28, three trials, low-quality evidence).There is evidence that there was no difference in the risk for caesarean delivery between remifentanil (PCA) and other opioids (IV/IM) (RR 0.63, 95% CI 0.30 to 1.32, ccc 0.01, four trials, low-quality evidence) and epidural analgesia (RR 1.0, 95% CI 0.82 to 1.22, ccc 0.01, nine trials, moderate-quality evidence), respectively. Pooled meta-analysis revealed an increased risk for caesarean section under remifentanil (PCA) compared to other opioids (PCA) (RR 2.78, 95% CI 0.99 to 7.82, two trials, very low-quality evidence). However, a wide range of clinically relevant and non-relevant treatment effects is compatible with this result.
AUTHORS' CONCLUSIONS
Based on the current systematic review, there is mostly low-quality evidence to inform practice and future research may significantly alter the current situation. The quality of evidence is mainly limited by poor quality of the studies, inconsistency, and imprecision. More research is needed on maternal and neonatal safety outcomes (maternal apnoea and respiratory depression, Apgar score) and on the optimal mode and regimen of remifentanil administration to provide highest efficacy with reasonable adverse effects for mothers and their newborns.
Topics: Analgesia, Epidural; Analgesia, Obstetrical; Analgesia, Patient-Controlled; Analgesics, Opioid; Apnea; Cesarean Section; Female; Humans; Infant, Newborn; Labor Pain; Pain Measurement; Patient Satisfaction; Piperidines; Pregnancy; Randomized Controlled Trials as Topic; Remifentanil
PubMed: 28407220
DOI: 10.1002/14651858.CD011989.pub2 -
The Cochrane Database of Systematic... Mar 2017This is an update of the review published in Issue 4, 2003. Bone metastasis cause severe pain as well as pathological fractures, hypercalcaemia and spinal cord... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
This is an update of the review published in Issue 4, 2003. Bone metastasis cause severe pain as well as pathological fractures, hypercalcaemia and spinal cord compression. Treatment strategies currently available to relieve pain from bone metastases include analgesia, radiotherapy, surgery, chemotherapy, hormone therapy, radioisotopes and bisphosphonates.
OBJECTIVES
To determine efficacy and safety of radioisotopes in patients with bone metastases to improve metastatic pain, decrease number of complications due to bone metastases and improve patient survival.
SEARCH METHODS
We sought randomised controlled trials (RCTs) in MEDLINE, EMBASE, CENTRAL, and the PaPaS Trials Register up to October 2010.
SELECTION CRITERIA
Studies selected had metastatic bone pain as a major outcome after treatment with a radioisotope, compared with placebo or another radioisotope.
DATA COLLECTION AND ANALYSIS
We assessed the risk of bias of included studies by their sequence generation, allocation concealment, blinding of study participants, researchers and outcome assessors, and incomplete outcome data. Two review authors extracted data. We performed statistical analysis as an "available case" analysis, and calculated global estimates of effect using a random-effects model. We also performed an intention-to-treat (ITT) sensitivity analysis.
MAIN RESULTS
This update includes 15 studies (1146 analyzed participants): four (325 participants) already included and 11 new (821 participants). Only three studies had a low risk of bias. We observed a small benefit of radioisotopes for complete relief (risk ratio (RR) 2.10, 95% CI 1.32 to 3.35; Number needed to treat to benefit (NNT) = 5) and complete/partial relief (RR 1.72, 95% CI 1.13 to 2.63; NNT = 4) in the short and medium term (eight studies, 499 participants). There is no conclusive evidence to demonstrate that radioisotopes modify the use of analgesia with respect to placebo. Leucocytopenia and thrombocytopenia are secondary effects significantly associated with the administration of radioisotopes (RR 5.03; 95% CI 1.35 to 18.70; Number needed to treat to harm (NNH) = 13). Pain flares were not higher in the radioisotopes group (RR 0.74; 95% CI 0.27 to 2.06). There are scarce data of moderate quality when comparing Strontium-89 (Sr) with Samarium-153 (Sm), Rhenium-186 (Re) and Phosphorus-32 (P). We observed no significant differences between treatments. Similarly, we observed no differences when we compared different doses of Sm (0.5 versus 1.0 mCi).
AUTHORS' CONCLUSIONS
This update adds new evidence on efficacy of radioisotopes versus placebo, Sr compared with other radioisotopes, and dose-comparisons of Sm and Re. There is some evidence indicating that radioisotopes may provide complete reduction in pain over one to six months with no increase in analgesic use, but severe adverse effects (leucocytopenia and thrombocytopenia) are frequent.
Topics: Bone Neoplasms; Fractures, Bone; Humans; Hypercalcemia; Pain; Pain Measurement; Phosphorus Radioisotopes; Radioisotopes; Randomized Controlled Trials as Topic; Ruthenium Radioisotopes; Samarium; Spinal Cord Compression; Strontium Radioisotopes
PubMed: 28334435
DOI: 10.1002/14651858.CD003347.pub3