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Experimental Biology and Medicine... Nov 2023The opioid epidemic has become a serious national crisis in the United States. An indepth systematic analysis of opioid-related adverse events (AEs) can clarify the...
The opioid epidemic has become a serious national crisis in the United States. An indepth systematic analysis of opioid-related adverse events (AEs) can clarify the risks presented by opioid exposure, as well as the individual risk profiles of specific opioid drugs and the potential relationships among the opioids. In this study, 92 opioids were identified from the list of all Food and Drug Administration (FDA)-approved drugs, annotated by RxNorm and were classified into 13 opioid groups: buprenorphine, codeine, dihydrocodeine, fentanyl, hydrocodone, hydromorphone, meperidine, methadone, morphine, oxycodone, oxymorphone, tapentadol, and tramadol. A total of 14,970,399 AE reports were retrieved and downloaded from the FDA Adverse Events Reporting System (FAERS) from 2004, Quarter 1 to 2020, Quarter 3. After data processing, Empirical Bayes Geometric Mean (EBGM) was then applied which identified 3317 pairs of potential risk signals within the 13 opioid groups. Based on these potential safety signals, a comparative analysis was pursued to provide a global overview of opioid-related AEs for all 13 groups of FDA-approved prescription opioids. The top 10 most reported AEs for each opioid class were then presented. Both network analysis and hierarchical clustering analysis were conducted to further explore the relationship between opioids. Results from the network analysis revealed a close association among fentanyl, oxycodone, hydrocodone, and hydromorphone, which shared more than 22 AEs. In addition, much less commonly reported AEs were shared among dihydrocodeine, meperidine, oxymorphone, and tapentadol. On the contrary, the hierarchical clustering analysis further categorized the 13 opioid classes into two groups by comparing the full profiles of presence/absence of AEs. The results of network analysis and hierarchical clustering analysis were not only consistent and cross-validated each other but also provided a better and deeper understanding of the associations and relationships between the 13 opioid groups with respect to their adverse effect profiles.
Topics: Analgesics, Opioid; Bayes Theorem; Data Mining; Fentanyl; Hydrocodone; Hydromorphone; Meperidine; Oxycodone; Oxymorphone; Tapentadol; United States
PubMed: 38158803
DOI: 10.1177/15353702231211860 -
International Wound Journal Feb 2023Pain and wound after haemorrhoidectomy constantly bothered the patient's convenience. Recurrently, topical sucralfate is used to treat excoriations and burns. It is... (Meta-Analysis)
Meta-Analysis
The efficacy of topical sucralfate in improving pain and wound healing after haemorrhoidectomy procedure: A systematic review, meta-analysis, and meta-regression of randomised clinical trials.
Pain and wound after haemorrhoidectomy constantly bothered the patient's convenience. Recurrently, topical sucralfate is used to treat excoriations and burns. It is considered to enhance epidermal growth and tissue granulation, thus, alleviating patients' problems. This study evaluated topical sucralfate's feasibility, safety, and superiority after haemorrhoidectomy. We searched randomised controlled trial (RCT) studies in PubMed, Google Scholar, Europe PMC, and ClinicalTrials.gov until March 29th, 2022. We investigated the influence of topical sucralfate on pain score postoperatively (24 hours, 7 days, and 14 days), pethidine usage, diclofenac usage, and wound healing rate compared to placebo. This study was conducted following the PRISMA guidelines. This study sorted the final six studies with 439 patients underwent haemorrhoidectomy. Topical sucralfate demonstrated significant outcomes on VAS 24 hours post-operative [Std. Mean Difference -1.00 (95% CI -1.70, -0.31), P = .005], VAS 7 days post-operative [Std. Mean Difference -2.29 (95% CI -3.34, -1.25), P < .0001], VAS 14 days post-operative [Std. Mean Difference -1.88 (95% CI -2.74, -1.01), P < .0001], pethidine usage within 24 hours post-operative [Std. Mean Difference -0.62 (95% CI -0.96, -0.27), P = .0004], diclofenac usage 7 days post-operative [Std. Mean Difference -1.76 (95% CI -2.61, -0.92), P < .0001], diclofenac usage 14 days post-operative [Std. Mean Difference -1.64 (95% CI -2.38, -0.91), P < .0001], and wound healing rate at 28-day post-operative [RR 1.45 (95% CI 1.25-1.68), P < .00001]. Topical sucralfate alleviated pain, improved wound healing, and minimised the usage of pethidine and diclofenac compared to placebo.
Topics: Humans; Diclofenac; Hemorrhoidectomy; Meperidine; Pain, Postoperative; Randomized Controlled Trials as Topic; Sucralfate; Wound Healing
PubMed: 35864080
DOI: 10.1111/iwj.13901 -
Journal of Obstetrics and Gynaecology... Dec 2020This systematic review and meta-analysis assessed the effectiveness and safety of camylofin compared with other antispasmodics (drotaverine, hyoscine, valethamate,... (Review)
Review
This systematic review and meta-analysis assessed the effectiveness and safety of camylofin compared with other antispasmodics (drotaverine, hyoscine, valethamate, phloroglucinol, and meperidine) in labor augmentation. A systematic literature search until March 27, 2018, was performed, and data on the cervical dilatation rate (CDR) and duration of stages of labor reported in 39 eligible articles were analyzed using a random-effects model. CDR was significantly higher (0.38 cm/h, 95% confidence interval (CI) 0.10 to 0.67, = 0.007), and the duration of the first stage of labor was significantly shorter (- 41.21 minutes, 95% CI, - 77.19 to - 5.22, = 0.02) in women receiving camylofin than those receiving other antispasmodics for labor augmentation. CDR was significantly higher with camylofin compared with valethamate (0.6 cm/h, 95% CI 0.4 to 0.9, < 0.0001) and hyoscine (20 mg) (0.5 cm/h, 95% CI 0.1 to 0.8, = 0.02). The duration of the first stage of labor was significantly shorter with camylofin compared with hyoscine (20 mg) (- 59.9 min, 95% CI, - 117.9 to - 1.8, = 0.04). However, CDR and the duration of first stage of labor were not statistically different between camylofin and drotaverine groups. The percentage of women having nausea and vomiting, cervical/vaginal tear, and postpartum hemorrhage were comparable with all antispasmodics, whereas tachycardia was least reported in women receiving camylofin (3, 2.07%) than those receiving other antispasmodics. This meta-analysis demonstrated the benefit of camylofin in labor augmentation with a faster CDR and reduction in the active first stage of labor in Indian women.
PubMed: 33417640
DOI: 10.1007/s13224-020-01343-3 -
BMC Anesthesiology Aug 2020Shivering is a common side effect in women having cesarean delivery (CD) under spinal anesthesia, which can be bothersome to the patient, and it can also interfere with... (Meta-Analysis)
Meta-Analysis
Effect of intrathecal lipophilic opioids on the incidence of shivering in women undergoing cesarean delivery after spinal anesthesia: a systematic review and bayesian network meta- analysis of randomized controlled trials.
BACKGROUND
Shivering is a common side effect in women having cesarean delivery (CD) under spinal anesthesia, which can be bothersome to the patient, and it can also interfere with perioperative monitoring. In several studies, the intrathecal (IT) addition of a lipophilic opioid to local anesthetics has been shown to decrease the incidence of shivering.
OBJECTIVE
We performed this network meta-analysis to evaluate the effects of intrathecal lipophilic opioids in preventing the incidence of shivering in patients undergoing CD.
METHODS
This review was planned according to the PRISMA for Network Meta-Analysis (PRISMA-NMA) guidelines. An English literature search of multiple electronic databases was conducted. We included randomized controlled trials (RCTs) that reported on the incidence of shivering, with study groups receiving either IT fentanyl, sufentanil, or meperidine in women undergoing CD under spinal anesthesia. Quality of the studies was assessed using the modified Oxford scoring system. Using random-effects modeling, dichotomous data were extracted and summarized using odds ratio (OR) with a 95% credible interval (CrI). Statistical analysis was conducted using R studio version 1.0.153 - Inc.
RESULTS
Twenty-one studies consisting of 1433 patients (Control group: 590 patients in twenty-one studies; Fentanyl group:199 patients in seven studies; Sufentanil group: 156 patients in five studies; Meperidine group: 488 patients in ten studies) met the inclusion criteria for this systematic review investigating the effect of intrathecal lipophilic opioids in preventing the incidence of shivering in women undergoing cesarean delivery under spinal anesthesia. Methodological validity scores ranged from 3 to 7. The Bayesian mixed network estimate showed the incidence of shivering was significantly lower with IT fentanyl (pooled odds ratio (OR): 0.13; 95% credible interval (CrI): 0.04 to 0.35; P = 0.0004) and IT meperidine (OR: 0.12; 95% CrI: 0.05 to 0.29; P < 0.00001), but not with IT sufentanil (OR: 0.37; 95% CrI: 0.11 to 1.22; P = 0.23). The IT fentanyl group had a significantly lower incidence of intraoperative discomfort [Risk Ratio (RR): 0.19; 95% CI: 0.10-0.35; P < 0.00001], the IT sufentanil group had a significantly higher incidence of pruritus (RR: 6.18; 95% CI: 1.18-32.46; P = 0.03) The IT meperidine group had a significantly lower incidence of intraoperative discomfort (2.7% vs. 13.6%; RR: 0.22; 95% CI: 0.09-0.55; P = 0.001), but there was a significant increase in nausea and vomiting (IT meperidine group vs. Control group: 42.7% vs. 19.4%; RR: 2.56; 95% CI: 1.14-5.75; P = 0.02). Meta-regression analysis based on the opioid dose and quality of the study did not impact the final inference of our result.
CONCLUSION
IT fentanyl significantly decreased the incidence of shivering in women undergoing CD under spinal anesthesia without increasing maternal adverse events, confirming that routine use in this patient population is a good choice. IT sufentanil did not decrease the incidence of shivering. IT meperidine decreased the incidence and severity of shivering, but its use was also associated with significant nausea and vomiting.
Topics: Analgesics, Opioid; Anesthesia, Obstetrical; Anesthesia, Spinal; Bayes Theorem; Cesarean Section; Female; Fentanyl; Humans; Incidence; Injections, Spinal; Network Meta-Analysis; Postoperative Nausea and Vomiting; Pregnancy; Randomized Controlled Trials as Topic; Shivering; Sufentanil
PubMed: 32847522
DOI: 10.1186/s12871-020-01116-5 -
Anesthesiology and Pain Medicine Apr 2020Spinal anesthesia is the most preferred method for cesarean section. This meta-analysis was performed to determine the effect of minimum and maximum intrathecal doses of...
CONTEXT
Spinal anesthesia is the most preferred method for cesarean section. This meta-analysis was performed to determine the effect of minimum and maximum intrathecal doses of meperidine (pethidine) [5 to 40 mg] on the maternal and newborn outcomes after cesarean section.
EVIDENCE ACQUISITION
The data were collected through the systematic search in the ISI, PubMed, Scopus, Google Scholar, Barakat, MagIran, SID, Irandoc, and EMBASE medical databases. Eighteen clinical trial studies with 1,494 patients were included.
RESULTS
Patients who had received intrathecal meperidine had experienced lower shivering, relative risk [RR] = 0.34 (95% CI = 0.23, 0.48) and longer analgesia, [standard mean difference (SMD)] = 7.67 (95% CI = 1.85, 13.49) after the surgery. Moreover, RR of nausea = 1.37 (95% CI = 1.13, 1.66), vomiting RR = 2.02 (95% CI = 1.28, 3.20), and pruritus RR = 9.26 (95% CI = 4.17, 20.58) was higher in the pethidine group than in the control group. There was no statistically significant difference in the Apgar score at one-minute RR = 0.99 (95% CI = 0.9, 1.09), at five-minute RR = 0.93 (95% CI = 0.87, 1.08), maternal hypotension RR = 1.00 (95% CI = 0.87, 1.15), and maternal sensory and motor blockade durations, SMD = -1.72 (95% CI = -3.78.0.34) and SMD = -4.38 (95% CI = -9.19, 0.44), respectively in the two pethidine and control groups.
CONCLUSIONS
Intrathecal meperidine can reduce shivering and increase the duration of postoperative analgesia, though it increases the relative risk of nausea, vomiting, and pruritus. No significant difference was found both in the Apgar score, maternal hypotension, and duration of the motor and sensory block.
PubMed: 32637349
DOI: 10.5812/aapm.100375 -
Pain Physician Nov 2019Opioid medications are frequently used effectively for analgesia in acute settings, however, they are associated with dependence and addiction, and were implicated in...
BACKGROUND
Opioid medications are frequently used effectively for analgesia in acute settings, however, they are associated with dependence and addiction, and were implicated in 47,600 American fatalities in 2017. Evidence suggests that despite guidelines and professional body recommendations, acute prescribing remains highly variable. Educational interventions targeting prescribers have potential to optimize prescribing in-line with evidence-based best practice.
OBJECTIVES
To identify the objective impacts of education interventions on opioid prescribing in the acute care setting.
STUDY DESIGN
A systematic literature review.
SETTING
The electronic databases MEDLINE, Embase, and Cochrane for works published until December 31, 2018. Bibliographies of relevant studies and the gray literature were also searched.
METHODS
Databases were searched for interventional studies (clinical trials and pre- and poststudies). Studies describing an educational intervention delivered to clinicians and reporting at least one objective measure of opioid use in the acute care setting were included. Studies reporting only subjective outcomes and those focused on chronic pain or set in primary care were excluded. Two reviewers (RB, TB) extracted data and assessed the quality of included studies using the Downs and Black Tool.
RESULTS
Nine studies met inclusion criteria; all used pre- and postdesigns. Three studies described stand-alone education, and the others described multifaceted interventions. All 9 interventions significantly reduced at least one of the following: high-risk agent use including meperidine use by up to 71%; total or daily dosage of opioids at discharge, including median morphine milligram equivalence (MME) from 90 mg to 45 mg per patient; and quantity of medications such as oxycodone supplied to patients, halved in one study from 6,170 expected to 2,932 supplied tablets. No increase in pain complaints or prescription refill requests were reported in those studies assessing these outcomes. The longest study examined prescribing 15 months after education delivery, reporting sustained practice changes.
LIMITATIONS
Overall study quality was fair to poor. Significant heterogeneity in settings, patient groups, methodologies, and outcomes prevented pooled quantitative analysis. No studies examined all available opioid agents or formulations.
CONCLUSIONS
These findings support prescriber education as an effective strategy to reduce opioid use and optimize prescribing in acute settings. Further research, particularly high quality randomized studies, describing the impact of education on all available opioid formulations and total MME is required. Reviewing the existing literature has offered useful models that can be implemented to improve care with opioid prescribing in acute settings.
KEY WORDS
Opioids, education, physician education, prescriber education, opioid education, opioid prescribing, systematic review, prescriptions, prevention.
Topics: Analgesics, Opioid; Drug Prescriptions; Humans; Opioid-Related Disorders; Oxycodone; Pain; Practice Patterns, Physicians'; Primary Health Care
PubMed: 31775401
DOI: No ID Found -
The Cochrane Database of Systematic... Jan 2019Laparoscopy is a common procedure used to diagnose and treat various gynaecological conditions. Shoulder-tip pain (STP) as a result of the laparoscopy occurs in up to... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Laparoscopy is a common procedure used to diagnose and treat various gynaecological conditions. Shoulder-tip pain (STP) as a result of the laparoscopy occurs in up to 80% of women, with potential for significant morbidity, delayed discharge and readmission. Interventions at the time of gynaecological laparoscopy have been developed in an attempt to reduce the incidence and severity of STP.
OBJECTIVES
To determine the effectiveness and safety of methods for reducing the incidence and severity of shoulder-tip pain (STP) following gynaecological laparoscopy.
SEARCH METHODS
We searched the following databases: Cochrane Gynaecology and Fertility (CGF) Specialised Register, the Cochrane Central Register of Studies Online (CRSO), MEDLINE, Embase, PsycINFO and CINAHL from inception to 8 August 2018. We also searched the reference lists of relevant articles and registers of ongoing trials.
SELECTION CRITERIA
Randomised controlled trials (RCTs) of interventions used during or immediately after gynaecological laparoscopy to reduce the incidence or severity of STP.
DATA COLLECTION AND ANALYSIS
We used standard methodological procedures expected by Cochrane. Primary outcomes: incidence or severity of STP and adverse events of the interventions; secondary outcomes: analgesia usage, delay in discharge, readmission rates, quality-of-life scores and healthcare costs.
MAIN RESULTS
We included 32 studies (3284 women). Laparoscopic procedures in these studies varied from diagnostic procedures to complex operations. The quality of the evidence ranged from very low to moderate. The main limitations were risk of bias, imprecision and inconsistency.Specific technique versus "standard" technique for releasing the pneumoperitoneumUse of a specific technique of releasing the pneumoperitoneum (pulmonary recruitment manoeuvre, extended assisted ventilation or actively aspirating intra-abdominal gas) reduced the severity of STP at 24 hours (standardised mean difference (SMD) -0.66, 95% confidence interval (CI) -0.82 to -0.50; 5 RCTs; 670 participants; I = 0%, low-quality evidence) and reduced analgesia usage (SMD -0.53, 95% CI -0.70 to -0.35; 4 RCTs; 570 participants; I = 91%, low-quality evidence). There appeared to be little or no difference in the incidence of STP at 24 hours (odds ratio (OR) 0.87, 95% CI 0.41 to 1.82; 1 RCT; 118 participants; low-quality evidence).No adverse events occurred in the only study assessing this outcome.Fluid instillation versus no fluid instillationFluid instillation is probably associated with a reduction in STP incidence (OR 0.38, 95% CI 0.22 to 0.66; 2 RCTs; 220 participants; I = 0%, moderate-quality evidence) and severity (mean difference (MD) (0 to 10 visual analogue scale (VAS) scale) -2.27, 95% CI -3.06 to -1.48; 2 RCTs; 220 participants; I = 29%, moderate-quality evidence) at 24 hours, and may reduce analgesia usage (MD -12.02, 95% CI -23.97 to -0.06; 2 RCTs; 205 participants, low-quality evidence).No study measured adverse events.Intraperitoneal drain versus no intraperitoneal drainUsing an intraperitoneal drain may reduce the incidence of STP at 24 hours (OR 0.30, 95% CI 0.20 to 0.46; 3 RCTs; 417 participants; I = 90%, low-quality evidence) and may reduce analgesia use within 48 hours post-operatively (SMD -1.84, 95% CI -2.14 to -1.54; 2 RCTs; 253 participants; I = 90%). We are uncertain whether it reduces the severity of STP at 24 hours, as the evidence was very low quality (MD (0 to 10 VAS scale) -1.85, 95% CI -2.15 to -1.55; 3 RCTs; 320 participants; I = 70%).No study measured adverse events.Subdiaphragmatic intraperitoneal local anaesthetic versus control (no fluid instillation, normal saline or Ringer's lactate)There is probably little or no difference between the groups in incidence of STP (OR 0.72, 95% CI 0.42 to 1.23; 4 RCTs; 336 participants; I = 0%; moderate-quality evidence) and there may be no difference in STP severity (MD -1.13, 95% CI -2.52 to 0.26; 1 RCT; 50 participants; low-quality evidence), both measured at 24 hours. However, the intervention may reduce post-operative analgesia use (SMD-0.57, 95% CI -0.94 to -0.21; 2 RCTs; 129 participants; I = 51%, low-quality evidence).No adverse events occurred in any study.Local anaesthetic into peritoneal cavity (not subdiaphragmatic) versus normal salineLocal anaesthetic into the peritoneal cavity may reduce the incidence of STP at 4 to 8 hours post-operatively (OR 0.23, 95% CI 0.06 to 0.93; 2 RCTs; 157 participants; I = 56%; low-quality evidence). Our other outcomes of interest were not assessed.Warmed, or warmed and humidified CO versus unwarmed and unhumidified COThere may be no difference between these interventions in incidence of STP at 24 to 48 hours (OR 0.81 95% CI 0.45 to 1.49; 2 RCTs; 194 participants; I = 12%; low-quality evidence) or in analgesia usage within 48 hours (MD -4.97 mg morphine, 95% CI -11.25 to 1.31; 1 RCT; 95 participants; low-quality evidence); there is probably little or no difference in STP severity at 24 hours (MD (0 to 10 VAS scale) 0.11, 95% CI -0.75 to 0.97; 2 RCTs; 157 participants; I = 50%; moderate-quality evidence).No study measured adverse events.Gasless laparoscopy versus CO insufflationGasless laparoscopy may be associated with increased severity of STP within 72 hours post-operatively when compared with standard treatment (MD 3.8 (0 to 30 VAS scale), 95% CI 0.76 to 6.84; 1 RCT; 54 participants, low-quality evidence), and there may be no difference in the risk of adverse events (OR 2.56, 95% CI 0.25 to 26.28; 1 RCT; 54 participants; low-quality evidence).No study measured the incidence of STP.
AUTHORS' CONCLUSIONS
There is low to moderate-quality evidence that the following interventions are associated with a reduction in the incidence or severity, or both, of STP, or a reduction in analgesia requirements for women undergoing gynaecological laparoscopy: a specific technique for releasing the pneumoperitoneum; intraperitoneal fluid instillation; an intraperitoneal drain; and local anaesthetic applied to the peritoneal cavity (not subdiaphragmatic).There is low to moderate-quality evidence that subdiaphragmatic intraperitoneal local anaesthetic and warmed and humidified insufflating gas may not make a difference to the incidence or severity of STP.There is low-quality evidence that gasless laparoscopy may increase the severity of STP, compared with standard treatment.Few studies reported data on adverse events. Some potentially useful interventions have not been studied by RCTs of gynaecological laparoscopy.
Topics: Acetaminophen; Analgesics; Anti-Inflammatory Agents, Non-Steroidal; Carbon Dioxide; Diclofenac; Drainage; Female; Gynecologic Surgical Procedures; Gynecological Examination; Humans; Incidence; Insufflation; Laparoscopy; Meperidine; Pain Measurement; Pain, Procedural; Pirinitramide; Pneumoperitoneum; Randomized Controlled Trials as Topic; Shoulder Pain
PubMed: 30699235
DOI: 10.1002/14651858.CD011101.pub2 -
Brazilian Journal of Anesthesiology... 2019The importance and benefits of breastfeeding for the babies and mothers are well established and documented in the literature. However, it is frequent that lactating...
INTRODUCTION
The importance and benefits of breastfeeding for the babies and mothers are well established and documented in the literature. However, it is frequent that lactating mothers need to undergo general or spinal anesthesia and, due to the lack of information, many of them interrupt breastfeeding after anesthesia. There are limited data available regarding anesthetics transfer to breast milk. This review aims to develop some considerations and recommendations based on available literature.
METHODS
A systematic search of the literature was conducted by using the following health science databases: Embase, Lilacs, Pubmed, Scopus, and Web of Science. The latest literature search was performed on April 6, 2018. Additional literature search was made via the World Health Organization's website. We used the following terms for the search strategy: “Anesthesia” and “Breastfeeding”, and their derivatives.
RESULTS
In this research, 599 registers were found, and 549 had been excluded by different reasons. Fifty manuscripts have been included, with different designs of studies: prospective trials, retrospective observational studies, reviews, case reports, randomized clinical trials, case–control, and website access. Small concentrations of the most anesthetic agents, are transferred to the breast milk; however, their administration seem to be safe for lactating mothers when administered as a single dose during anesthesia and this should not contraindicate the breastfeeding. On the other hand, high-doses, continuous or repeated administration of drugs increase the risk of adverse effects on neonates, and should be avoided. Few drugs, such as diazepam and meperidine, produce adverse effects on breastfed babies even in single doses. Dexmedetomidine seems to be safe if breastfeeding starts 24 h after discontinuation of the drug.
CONCLUSIONS
Most of the anesthetic drugs are safe for nursing mothers and offer low risk to the breastfed neonates when administered in single-dose. However, high-dose and repeated administration of drugs significantly increase the risk of adverse effects on neonates. Moreover, diazepam and meperidine should be avoided in nursing women. Finally, anesthesiologists and pediatricians should consider individual risk/benefit, with special attention to premature neonates or babies with concurrent diseases since they are more susceptible to adverse effects.
Topics: Anesthesia; Anesthetics; Breast Feeding; Dose-Response Relationship, Drug; Female; Humans; Infant; Infant, Newborn; Lactation; Milk, Human; Randomized Controlled Trials as Topic; Time Factors
PubMed: 30651201
DOI: 10.1016/j.bjan.2018.11.006 -
The Cochrane Database of Systematic... Dec 2018Children's fear about dental treatment may lead to behaviour management problems for the dentist, which can be a barrier to the successful dental treatment of children.... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Children's fear about dental treatment may lead to behaviour management problems for the dentist, which can be a barrier to the successful dental treatment of children. Sedation can be used to relieve anxiety and manage behaviour in children undergoing dental treatment. There is a need to determine from published research which agents, dosages and regimens are effective. This is the second update of the Cochrane Review first published in 2005 and previously updated in 2012.
OBJECTIVES
To evaluate the efficacy and relative efficacy of conscious sedation agents and dosages for behaviour management in paediatric dentistry.
SEARCH METHODS
Cochrane Oral Health's Information Specialist searched the following databases: Cochrane Oral Health's Trials Register (to 22 February 2018); the Cochrane Central Register of Controlled Trials (CENTRAL; 2018, Issue 1) in the Cochrane Library (searched 22 February 2018); MEDLINE Ovid (1946 to 22 February 2018); and Embase Ovid (1980 to 22 February 2018). The US National Institutes of Health Ongoing Trials Register (ClinicalTrials.gov) and the World Health Organization International Clinical Trials Registry Platform were searched for ongoing trials. No restrictions were placed on the language or date of publication when searching the electronic databases.
SELECTION CRITERIA
Studies were selected if they met the following criteria: randomised controlled trials of conscious sedation comparing two or more drugs/techniques/placebo undertaken by the dentist or one of the dental team in children up to 16 years of age. We excluded cross-over trials.
DATA COLLECTION AND ANALYSIS
Two review authors independently extracted, in duplicate, information regarding methods, participants, interventions, outcome measures and results. Where information in trial reports was unclear or incomplete authors of trials were contacted. Trials were assessed for risk of bias. Cochrane statistical guidelines were followed.
MAIN RESULTS
We included 50 studies with a total of 3704 participants. Forty studies (81%) were at high risk of bias, nine (18%) were at unclear risk of bias, with just one assessed as at low risk of bias. There were 34 different sedatives used with or without inhalational nitrous oxide. Dosages, mode of administration and time of administration varied widely. Studies were grouped into placebo-controlled, dosage and head-to-head comparisons. Meta-analysis of the available data for the primary outcome (behaviour) was possible for studies investigating oral midazolam versus placebo only. There is moderate-certainty evidence from six small clinically heterogeneous studies at high or unclear risk of bias, that the use of oral midazolam in doses between 0.25 mg/kg to 1 mg/kg is associated with more co-operative behaviour compared to placebo; standardized mean difference (SMD) favoured midazolam (SMD 1.96, 95% confidence interval (CI) 1.59 to 2.33, P < 0.0001, I = 90%; 6 studies; 202 participants). It was not possible to draw conclusions regarding the secondary outcomes due to inconsistent or inadequate reporting or both.
AUTHORS' CONCLUSIONS
There is some moderate-certainty evidence that oral midazolam is an effective sedative agent for children undergoing dental treatment. There is a need for further well-designed and well-reported clinical trials to evaluate other potential sedation agents. Further recommendations for future research are described and it is suggested that future trials evaluate experimental regimens in comparison with oral midazolam or inhaled nitrous oxide.
Topics: Analgesics, Non-Narcotic; Anti-Anxiety Agents; Child; Chloral Hydrate; Dental Anxiety; Dental Care for Children; Humans; Hydroxyzine; Hypnotics and Sedatives; Meperidine; Midazolam; Nitrous Oxide; Preanesthetic Medication; Randomized Controlled Trials as Topic
PubMed: 30566228
DOI: 10.1002/14651858.CD003877.pub5 -
Minerva Anestesiologica Dec 2018Perioperative shivering during cesarean sections (CSs) under neuraxial anesthesia (NA) is clinically common but often under-treated. It may prominently increase oxygen...
INTRODUCTION
Perioperative shivering during cesarean sections (CSs) under neuraxial anesthesia (NA) is clinically common but often under-treated. It may prominently increase oxygen consumption, which can be catastrophic for parturients with ischemic cardiovascular disease. Thus, the prevention and treatment of shivering may be of great significance in parturients. The purpose of this systematic review was to investigate the effectiveness of several drugs on shivering prevention and treatment during CSs under NA.
EVIDENCE ACQUISITION
A literature search was carried out using PubMed, EMBASE and the Cochrane Library to identify relevant studies. After literature screening and information extraction, a systematic review was performed.
EVIDENCE SYNTHESIS
Eighteen randomized controlled trials met the inclusion criteria. Intrathecal dexmedetomidine effectively reduced shivering, but effectiveness depended on the dose administered. Intrathecal fentanyl, intrathecal sufentanil, intrathecal meperidine, intravenous ketamine and intravenous tramadol were beneficial for reducing shivering during CSs under NA. MgSO4 administered intrathecally resulted in transient alleviation of shivering, and the effect did not persist. Two trials investigated the antishivering effect of intravenous ondansetron. The medication appeared to be effective in one trial, but ineffective in the other.
CONCLUSIONS
Appropriate use of dexmedetomidine, fentanyl, sufentanil, ketamine, meperidine, tramadol and MgSO4 may effectively reduce the incidence and severity of shivering during CSs under NA, while trials on the effect of intravenous ondansetron reached inconclusive results.
Topics: Anesthesia, Epidural; Anesthesia, Obstetrical; Anesthesia, Spinal; Cesarean Section; Female; Humans; Intraoperative Complications; Pregnancy; Randomized Controlled Trials as Topic; Shivering
PubMed: 29945433
DOI: 10.23736/S0375-9393.18.12478-3