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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 -
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 -
The Cochrane Database of Systematic... May 2015Agitation is a common experience for people living with dementia, particularly as day-to-day function and cognition start to decline more. At the present time there are... (Review)
Review
BACKGROUND
Agitation is a common experience for people living with dementia, particularly as day-to-day function and cognition start to decline more. At the present time there are limited pharmacological options for relieving agitation and little is known about the safety and efficacy of opioid drugs in this setting.
OBJECTIVES
To determine the clinical efficacy and safety of opioids for agitation in people with dementia.
SEARCH METHODS
We searched ALOIS, the Cochrane Dementia and Cognitive Improvement Group Specialized Register, on 13 June 2014 using the terms: narcotic OR opioid OR opium OR morphine OR buprenorphine OR codeine OR dextromoramide OR diphenoxylate OR dipipanone OR dextropropoxyphene OR propoxyphene OR diamorphine OR dihydrocodeine OR alfentanil OR fentanyl OR remifentanil OR meptazinol OR methadone OR nalbuphine OR oxycodone OR papaveretum OR pentazocine OR meperidine OR pethidine OR phenazocine OR hydrocodone OR hydromorphone OR levorphanol OR oxymorphone OR butorphanol OR dezocine OR sufentanil OR ketobemidone.ALOIS contains records of clinical trials identified from monthly searches of a number of major healthcare databases such as MEDLINE, EMBASE and PscyINFO, as well as numerous trial registries and grey literature sources.
SELECTION CRITERIA
Randomised, controlled trials of opioids compared to placebo for agitation in people with dementia.
DATA COLLECTION AND ANALYSIS
Two authors independently assessed the studies identified by the search against the inclusion criteria.
MAIN RESULTS
There are currently no completed randomised, placebo controlled trials of opioids for agitation in dementia. There are two potentially relevant trials still in progress.
AUTHORS' CONCLUSIONS
We found insufficient evidence to establish the clinical efficacy and safety of opioids for agitation in people with dementia. There remains a lack of data to determine if or when opioids either relieve or exacerbate agitation. More evidence is needed to guide the effective, appropriate and safe use of opioids in dementia.
Topics: Analgesics, Opioid; Dementia; Humans; Psychomotor Agitation
PubMed: 25972091
DOI: 10.1002/14651858.CD009705.pub2 -
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 -
Annals of Emergency Medicine Dec 2008Despite guidelines recommending against opioids as first-line treatment for acute migraine, meperidine is the agent used most commonly in North American emergency... (Meta-Analysis)
Meta-Analysis Review
STUDY OBJECTIVE
Despite guidelines recommending against opioids as first-line treatment for acute migraine, meperidine is the agent used most commonly in North American emergency departments. Clinical trials performed to date have been small and have not arrived at consistent conclusions about the efficacy of meperidine. We performed a systematic review and meta-analysis to determine the relative efficacy and adverse effect profile of opioids compared with nonopioid active comparators for the treatment of acute migraine.
METHODS
We searched multiple sources (Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, CINAHL, and LILACS, emergency and headache medicine conference proceedings) for randomized controlled trials comparing parenteral opioid and nonopioid active comparators for the treatment of acute migraine headache. Our primary outcome was relief of headache. If this was unavailable, we accepted rescue medication use or we transformed visual analog scale change scores by using an established procedure. We grouped studies by comparator: a regimen containing dihydroergotamine, antiemetic alone, or ketorolac. For each study, we calculated an odds ratio (OR) of headache relief and then assessed clinical and statistical heterogeneity for the group of studies. We then pooled the ORs of headache relief with a random-effects model.
RESULTS
From 899 citations, 19 clinical trials were identified, of which 11 were appropriate and had available data. Four trials involving 254 patients compared meperidine to dihydroergotamine, 4 trials involving 248 patients compared meperidine to an antiemetic, and 3 trials involving 123 patients compared meperidine to ketorolac. Meperidine was less effective than dihydroergotamine at providing headache relief (OR=0.30; 95% confidence interval [CI] 0.09 to 0.97) and trended toward less efficacy than the antiemetics (OR=0.46; 95% CI 0.19 to 1.11); however, the efficacy of meperidine was similar to that of ketorolac (OR=1.75; 95% CI 0.84 to 3.61). Compared to dihydroergotamine, meperidine caused more sedation (OR=3.52; 95% CI 0.87 to 14.19) and dizziness (OR=8.67; 95% CI 2.66 to 28.23). Compared to the antiemetics, meperidine caused less akathisia (OR=0.10; 95% CI 0.02 to 0.57). Meperidine and ketorolac use resulted in similar rates of gastrointestinal adverse effects (OR=1.27; 95% CI 0.31 to 5.15) and sedation (OR=1.70; 95% CI 0.23 to 12.72).
CONCLUSION
Clinicians should consider alternatives to meperidine when treating acute migraine with injectable agents.
Topics: Analgesics, Non-Narcotic; Analgesics, Opioid; Anti-Inflammatory Agents, Non-Steroidal; Dihydroergotamine; Humans; Ketorolac; Meperidine; Migraine Disorders; Randomized Controlled Trials as Topic
PubMed: 18632186
DOI: 10.1016/j.annemergmed.2008.05.036 -
International Journal of Surgery... Mar 2018We performed a systematic review of various anaesthetic medications for endoscopic retrograde cholangiopancreatography (ERCP) and aimed to make a comprehensive... (Meta-Analysis)
Meta-Analysis Review
AIMS
We performed a systematic review of various anaesthetic medications for endoscopic retrograde cholangiopancreatography (ERCP) and aimed to make a comprehensive comparison based on a network meta-analysis.
METHODS
We searched globally recognized electronic databases, including PubMed, Cochrane Central and EMBASE, to retrieve relevant randomized controlled trials (RCTs) of anaesthetic medications for ERCP. Network meta-analysis was conducted by evaluating the procedure time, adverse effects and drug requirements. The cumulative probability P value was utilized to rank the medications under examination.
RESULTS
Seventeen RCTs that examined 1877 patients were included in this research. Under good convergence and efficiency, data analysis was performed using a consistency model. For the comparison of procedure times, we found that a combination of dexmedetomidine and ketamine (P = 0.19) or propofol plus pethidine (P = 0.18) seemed to be the two best medications for reducing procedure time. Additionally, midazolam combined with dexmedetomidine plus pethidine seemed to be the safest application for ERCP (P = 0.36). Propofol plus alfentanil also exhibited a good safety value (P = 0.28). For evaluation of drug requirements, the whole network connection could not be established; thus, comparisons in two subgroups were conducted. The results showed that midazolam combined with dexmedetomidine plus pethidine (P = 0.41) and propofol plus refentanil (P = 0.94) were superior to others in decreasing drug requirements.
CONCLUSIONS
Based on the objective results and our conclusions, we deemed that a combination of midazolam and dexmedetomidine was recommended, and propofol plus opioids also revealed great clinical value. However, we are still expecting more clinical research in the future.
Topics: Alfentanil; Analgesics, Opioid; Anesthetics; Cholangiopancreatography, Endoscopic Retrograde; Dexmedetomidine; Drug Therapy, Combination; Humans; Ketamine; Meperidine; Midazolam; Network Meta-Analysis; Operative Time; Propofol; Randomized Controlled Trials as Topic; Treatment Outcome
PubMed: 29367034
DOI: 10.1016/j.ijsu.2018.01.018 -
The Cochrane Database of Systematic... Jun 2018Parenteral opioids (intramuscular and intravenous drugs including patient-controlled analgesia) are used for pain relief in labour in many countries throughout the... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Parenteral opioids (intramuscular and intravenous drugs including patient-controlled analgesia) are used for pain relief in labour in many countries throughout the world. This review is an update of a review first published in 2010.
OBJECTIVES
To assess the effectiveness, safety and acceptability to women of different types, doses and modes of administration of parenteral opioid analgesia in labour. A second objective is to assess the effects of opioids in labour on the baby in terms of safety, condition at birth and early feeding.
SEARCH METHODS
We searched Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (11 May 2017) and reference lists of retrieved studies.
SELECTION CRITERIA
We included randomised controlled trials examining the use of intramuscular or intravenous opioids (including patient-controlled analgesia) for women in labour. Cluster-randomised trials were also eligible for inclusion, although none were identified. We did not include quasi-randomised trials. We looked at studies comparing an opioid with another opioid, placebo, no treatment, other non-pharmacological interventions (transcutaneous electrical nerve stimulation (TENS)) or inhaled analgesia.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed trials for inclusion and risk of bias, extracted data and checked them for accuracy. We assessed the quality of each evidence synthesis using the GRADE approach.
MAIN RESULTS
We included 70 studies that compared an opioid with placebo or no treatment, another opioid administered intramuscularly or intravenously or compared with TENS applied to the back. Sixty-one studies involving more than 8000 women contributed data to the review and these studies reported on 34 different comparisons; for many comparisons and outcomes only one study contributed data. All of the studies were conducted in hospital settings, on healthy women with uncomplicated pregnancies at 37 to 42 weeks' gestation. We excluded studies focusing on women with pre-eclampsia or pre-existing conditions or with a compromised fetus. Overall, the evidence was graded as low- or very low-quality regarding the analgesic effect of opioids and satisfaction with analgesia; evidence was downgraded because of study design limitations, and many of the studies were underpowered to detect differences between groups and so effect estimates were imprecise. Due to the large number of different comparisons, it was not possible to present GRADE findings for every comparison.For the comparison of intramuscular pethidine (50 mg/100 mg) versus placebo, no clear differences were found in maternal satisfaction with analgesia measured during labour (number of women satisfied or very satisfied after 30 minutes: 50 women; 1 trial; risk ratio (RR) 7.00, 95% confidence interval (CI) 0.38 to 128.87, very low-quality evidence), or number of women requesting an epidural (50 women; 1 trial; RR 0.50, 95% CI 0.14 to 1.78; very low-quality evidence). Pain scores (reduction in visual analogue scale (VAS) score of at least 40 mm: 50 women; 1 trial; RR 25, 95% CI 1.56 to 400, low-quality evidence) and pain measured in labour (women reporting pain relief to be "good" or "fair" within one hour of administration: 116 women; 1 trial; RR 1.75, 95% CI 1.24 to 2.47, low-quality evidence) were both reduced in the pethidine group, and fewer women requested any additional analgesia (50 women; 1 trial; RR 0.71, 95% CI 0.54 to 0.94, low-quality evidence).There was limited information on adverse effects and harm to women and babies. There were few results that clearly showed that one opioid was more effective than another. Overall, findings indicated that parenteral opioids provided some pain relief and moderate satisfaction with analgesia in labour. Opioid drugs were associated with maternal nausea, vomiting and drowsiness, although different opioid drugs were associated with different adverse effects. There was no clear evidence of adverse effects of opioids on the newborn. We did not have sufficient evidence to assess which opioid drug provided the best pain relief with the least adverse effects.
AUTHORS' CONCLUSIONS
Though most evidence is of low- or very-low quality, for healthy women with an uncomplicated pregnancy who are giving birth at 37 to 42 weeks, parenteral opioids appear to provide some relief from pain in labour but are associated with drowsiness, nausea, and vomiting in the woman. Effects on the newborn are unclear. Maternal satisfaction with opioid analgesia was largely unreported. The review needs to be examined alongside related Cochrane reviews. More research is needed to determine which analgesic intervention is most effective, and provides greatest satisfaction to women with acceptable adverse effects for mothers and their newborn.
Topics: Analgesia, Obstetrical; Analgesics, Opioid; Female; Humans; Injections, Intramuscular; Injections, Intravenous; Labor Pain; Meperidine; Pregnancy; Randomized Controlled Trials as Topic; Transcutaneous Electric Nerve Stimulation
PubMed: 29870574
DOI: 10.1002/14651858.CD007396.pub3 -
The Cochrane Database of Systematic... Sep 2010Eclampsia, the occurrence of a seizure in association with pre-eclampsia, is a rare but serious complication of pregnancy. A number of different anticonvulsants have... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Eclampsia, the occurrence of a seizure in association with pre-eclampsia, is a rare but serious complication of pregnancy. A number of different anticonvulsants have been used to control eclamptic fits and to prevent further seizures.
OBJECTIVES
The objective of this review was to assess the effects of magnesium sulphate compared with lytic cocktail (usually chlorpromazine, promethazine and pethidine) when used for the care of women with eclampsia. Magnesium sulphate is compared with diazepam and with phenytoin in other Cochrane reviews.
SEARCH STRATEGY
We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (July 2010) and the Cochrane Central Register of Trials (The Cochrane Library 2010, Issue 2).
SELECTION CRITERIA
Randomised trials comparing magnesium sulphate (intravenous or intramuscular administration) with lytic cocktail for women with a clinical diagnosis of eclampsia.
DATA COLLECTION AND ANALYSIS
Two review authors (L Duley and D Chou) assessed trial quality and extracted data.
MAIN RESULTS
We included three small trials (total 397 women) of average quality in the review. Magnesium sulphate was associated with fewer maternal deaths (risk ratio (RR) 0.14, 95% confidence interval (CI) 0.03 to 0.59; 3 trials, 397 women) and was better at preventing further seizures (RR 0.06, 95% CI 0.03 to 0.12; 3 trials, 397 women) than lytic cocktail. Magnesium sulphate was also associated with less respiratory depression (RR 0.12, 95% CI 0.02 to 0.91; 2 trials, 198 women), less coma (RR 0.04, 95% CI 0.00 to 0.74; 1 trial, 108 women), and less pneumonia (RR 0.20, 95% CI 0.06 to 0.67; 2 trials, 307 women). There was no clear difference in the RR for any death of the baby (RR 0.35, 95% CI 0.05 to 2.38, random effects; 2 trials, 177 babies).
AUTHORS' CONCLUSIONS
Magnesium sulphate, rather than lytic cocktail, for women with eclampsia reduces the RR of maternal death, of further seizures and of serious maternal morbidity (respiratory depression, coma, pneumonia). Magnesium sulphate is the anticonvulsant of choice for women with eclampsia; the use of lytic cocktail should be abandoned.
Topics: Anticonvulsants; Chlorpromazine; Drug Combinations; Eclampsia; Female; Humans; Magnesium Sulfate; Meperidine; Pregnancy; Promethazine; Randomized Controlled Trials as Topic
PubMed: 20824833
DOI: 10.1002/14651858.CD002960.pub2 -
Drugs & Aging Jun 2017There is substantial evidence that the use of opioids increases the risk of adverse outcomes such as delirium, but whether this risk differs between the various opioids... (Review)
Review
OBJECTIVE
There is substantial evidence that the use of opioids increases the risk of adverse outcomes such as delirium, but whether this risk differs between the various opioids remains controversial. In this systematic review, we evaluate and discuss possible differences in the risk of delirium from the use of various types of opioids in older patients.
METHODS
We performed a search in MEDLINE by combining search terms on delirium and opioids. A specific search filter for use in geriatric medicine was used. Quality was scored according to the quality assessment for cohort studies of the Dutch Cochrane Institute.
RESULTS
Six studies were included, all performed in surgical departments and all observational. No study was rated high quality, one was rated moderate quality, and five were rated low quality. Information about dose, route, and timing of administration of the opioid was frequently missing. Pain and other important risk factors of delirium were often not taken into account. Use of tramadol or meperidine was associated with an increased risk of delirium, whereas the use of morphine, fentanyl, oxycodone, and codeine were not, when compared with no opioid. Meperidine was also associated with an increased risk of delirium compared with other opioids, whereas tramadol was not. The risk of delirium appeared to be lower with hydromorphone or fentanyl, compared with other opioids. Numbers used for comparisons were small.
CONCLUSION
Some data suggest that meperidine may lead to a higher perioperative risk for delirium; however, high-quality studies that compare different opioids are lacking. Further comparative research is needed.
Topics: Aged; Analgesics, Opioid; Delirium; Humans; Hydromorphone; Meperidine; Morphine; Oxycodone; Pain; Pain Measurement; Risk Factors; Tramadol
PubMed: 28405945
DOI: 10.1007/s40266-017-0455-9 -
The Cochrane Database of Systematic... Mar 2015According to current recommendations a multimodal approach is believed to be the gold standard for postoperative pain treatment in children. However, several surveys in... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
According to current recommendations a multimodal approach is believed to be the gold standard for postoperative pain treatment in children. However, several surveys in the last few years demonstrated that postoperative pain in children is still a serious problem, mainly because opioids are avoided. One of the reasons for this is the fear of severe adverse events following opioid administration. Tramadol is a weak mu-opioid agonist and inhibits reuptake of noradrenaline and serotonin (5HT). Because of a relatively wide therapeutic window and a ceiling effect with a lower risk for severe adverse events (for example respiratory depression) tramadol is a widely used opioid in children. However, the exact efficacy and occurrence of adverse events following tramadol (in comparison with placebo or other opioids) for postoperative pain treatment in children and adolescents are currently not clear.
OBJECTIVES
To assess the effectiveness and side effect profile of tramadol for postoperative pain relief in children and adolescents undergoing different surgical procedures.
SEARCH METHODS
We searched the following electronic databases: the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2014, Issue 6), MEDLINE via PubMed (January 1966 to July 2014) and EMBASE via Ovid (January 1947 to July 2014). There were no restrictions regarding language or date of publication. The reference lists of all included trials were checked for additional studies.
SELECTION CRITERIA
All randomised controlled clinical trials investigating the perioperative administration of tramadol compared to placebo or other opioids for postoperative pain treatment in children and adolescents were included.
DATA COLLECTION AND ANALYSIS
Three review authors independently assessed the study eligibility, performed the data extraction and assessed the risk of bias of included trials.
MAIN RESULTS
Twenty randomised controlled trials involving 1170 patients were included in this systematic review. The overall risk of bias in included trials was assessed as unclear, because concealment of allocation processes and blinding of outcome assessors were poorly described. Due to inconsistent outcome reporting, data from 17 included trials could be pooled for some endpoints only. Eight trials compared tramadol administration with placebo and five trials found that the need for rescue analgesia in the postoperative care unit (PACU) was reduced in children receiving tramadol (RR 0.40; 95% CI 0.20 to 0.78; low quality evidence). Only one trial investigated the number of patients with moderate to severe pain, but a non-validated pain scale was used (very low quality evidence). Four trials compared morphine with tramadol administration. There was no clear evidence of difference in the need for rescue analgesia in the PACU (RR 1.25; 95% CI 0.83 to 1.89; low quality evidence) with tramadol compared with morphine. No trials could be pooled for the outcome 'number of patients with moderate to severe pain'. Three trials were included for the comparison of tramadol with nalbuphine. There was no clear evidence for the need for rescue analgesia in the PACU (RR 0,63; 95% CI 0.16 to 2.45; low quality evidence). Only one trial reported the number of patients with moderate to severe pain, but used a non-validated pain scale (very low quality evidence). Two out of six included trials, which compared pethidine with tramadol, reported the number of children with a need for rescue analgesia within the PACU and showed no clear evidence (RR 0.93; 95% CI 0.43 to 2.02; very low quality evidence). Two trials reported the number of patients with moderate to severe pain and showed a lower RR in patients treated with tramadol (RR 0.64; 95% CI 0.36 to 1.16; low quality evidence). Only one trial was included, which compared tramadol with fentanyl, reporting the number of patients with the need for rescue analgesia (very low quality evidence). Generally, adverse events were poorly reported. Most data could be pooled for the comparison with placebo focusing on the RR for postoperative nausea and vomiting (PONV) in the postoperative care unit and 24 h postoperation. Children treated with tramadol, compared to placebo, did not show clear evidence of benefit for PONV in the postoperative care unit (RR 0.84; 95% CI 0.28 to 2.52; moderate quality evidence) and 24 h postoperation (RR 0.78; 95% CI 0.54 to 1.12; moderate quality evidence).
AUTHORS' CONCLUSIONS
The overall evidence regarding tramadol for postoperative pain in children is currently low or very low and should be interpreted with caution due to small studies and methodological problems (different validated and non-validated pain scales with different pain triggers, missing sample size calculations and missing intention-to-treat analysis). Nevertheless, we demonstrated that tramadol administration might provide appropriate analgesia when compared to placebo; this is based on results showing reduced rescue analgesia in children treated with tramadol compared to placebo. In contrast, the evidence regarding the comparison with other opioids (for example morphine) was uncertain. Adverse events were only poorly reported, so an accurate risk-benefit analysis was not possible.
Topics: Adolescent; Analgesics, Opioid; Child; Child, Preschool; Female; Fentanyl; Humans; Infant; Male; Meperidine; Morphine; Nalbuphine; Pain, Postoperative; Randomized Controlled Trials as Topic; Tramadol
PubMed: 25785365
DOI: 10.1002/14651858.CD009574.pub2