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Journal of the Academy of... 2024Acute disturbance is a broad term referring to escalating behaviors secondary to a change in mental state, such as agitation, aggression, and violence. Available... (Review)
Review
Effectiveness and Safety of Intravenous Medications for the Management of Acute Disturbance (Agitation and Other Escalating Behaviors): A Systematic Review of Prospective Interventional Studies.
Acute disturbance is a broad term referring to escalating behaviors secondary to a change in mental state, such as agitation, aggression, and violence. Available management options include de-escalation techniques and rapid tranquilization, mostly via parenteral formulations of medication. While the intramuscular route has been extensively studied in a range of clinical settings, the same cannot be said for intravenous (IV); this is despite potential benefits, including rapid absorption and complete bioavailability. This systematic review analyzed existing evidence for effectiveness and safety of IV medication for management of acute disturbances. It followed a preregistered protocol (PROSPERO identification CRD42020216456) and is reported following the guidelines set by Preferred Reporting Items for Systematic Review and Meta-Analysis. APA PsycINFO, MEDLINE, and EMBASE databases were searched for eligible interventional studies up until May 30th, 2023. Data analysis was limited to narrative synthesis since primary outcome measures varied significantly. Results showed mixed but positive results for the effectiveness of IV dexmedetomidine, lorazepam, droperidol, and olanzapine. Evidence was more limited for IV haloperidol, ketamine, midazolam, chlorpromazine, and valproate. There was no eligible data on the use of IV clonazepam, clonidine, diazepam, diphenhydramine, propranolol, ziprasidone, fluphenazine, carbamazepine, or promethazine. Most studies reported favorable adverse event profiles, though they are unlikely to have been sufficiently powered to pick up rare serious events. In most cases, evidence was of low or mixed quality, accentuating the need for further standardized, large-scale, multi-arm randomized controlled trials with homogeneous outcome measures. Overall, this review suggests that IV medications may offer an effective alternative parenteral route of administration in acute disturbance, particularly in general hospital settings.
Topics: Humans; Administration, Intravenous; Psychomotor Agitation; Aggression; Antipsychotic Agents; Prospective Studies
PubMed: 38309683
DOI: 10.1016/j.jaclp.2024.01.004 -
Journal of Psychoactive Drugs 2020In the early 1990s, several studies reported the misuse of codeine and promethazine hydrochloride cough syrup. Since then, the combination of this pharmaceutical,...
In the early 1990s, several studies reported the misuse of codeine and promethazine hydrochloride cough syrup. Since then, the combination of this pharmaceutical, together with sprite or alcohol, known on the streets as "purple drank" or "lean", has become a popular drug among rap singers who promote its tranquilizing and euphoric effects through their music and videos. This review examines the "purple drank" phenomenon, taking into consideration its clinical and social implications. The study was conducted using PubMed, Scopus, and Web of Science as search engines, applying several inclusion and exclusion criteria and the string "Purple AND drank", resulting in 138 records. Seven papers that met our criteria were found. The risk of bias assessment, when applicable, was also considered, resulting in a low level of risk. Epidemiological data highlighted a heterogeneous diffusion of the misuse of this mixture, which is not exclusively linked to a specific type of user (African-American teenagers, athletes, and rappers), as previously reported in American newspapers and in the social media. New digital tools should be taken into consideration for further social and medical evaluations of this phenomenon.
Topics: Adolescent; Antitussive Agents; Codeine; Cough; Female; Humans; Male; Promethazine; Social Media; Young Adult
PubMed: 32748711
DOI: 10.1080/02791072.2020.1797250 -
Journal of Psychiatric Research Sep 2015We performed an updated systematic review and meta-analysis of randomized controlled trials (RCTs) of intramuscular (IM)-olanzapine (OLA-IM) versus controls in agitated... (Meta-Analysis)
Meta-Analysis Review
We performed an updated systematic review and meta-analysis of randomized controlled trials (RCTs) of intramuscular (IM)-olanzapine (OLA-IM) versus controls in agitated patients. The risk ratio, number-needed-to-treat/harm, and standardized mean difference based on a random effects model were calculated. We identified 13 RCTs (19 comparisons) as follows: 7 comparisons with 1059 patients for OLA-IM versus placebo; 5 comparisons with 613 patients for OLA-IM versus haloperidol (HAL)-IM; 2 comparisons with 108 patients for OLA-IM versus ziprasidone (ZIP)-IM; 2 comparisons with 110 patients for OLA-IM versus HAL-IM plus midazolam; and 3 comparisons with 412 patients for OLA-IM versus HAL-IM plus promethazine, 2 comparisons with 355 patients for OLA-IM versus lorazepam-IM (LOR-IM); and 1 comparison with 67 patients for OLA-IM versus HAL-IM plus LOR-IM. OLA-IM was superior to placebo in both Positive and Negative Syndrome Scale-Excited Component (PANSS-EC) and Agitation-Calmness Evaluation Scale (ACES) scores 2 h after first injection, and had a comparable side effect profile, including over sedation, extrapyramidal symptoms, akathisia, and anticholinergic use. While there was no significant difference in PANSS-EC scores after 2 h between OLA-IM and HAL-IM, OLA-IM outperformed HAL-IM in ACES after 2 h. Compared with HAL-IM, OLA-IM was associated with fewer side effects, including anticholinergic use, akathisia, extrapyramidal symptoms, and dystonia, and marginally less QT prolongation compared with HAL-IM. Based on our findings, OLA-IM is preferable to HAL-IM for the treatment of agitated patients. However, comparator data for ZIP-IM, LOR-IM and HAL-IM combination therapy were insufficient.
Topics: Antipsychotic Agents; Benzodiazepines; Haloperidol; Humans; Olanzapine; Psychomotor Agitation; Randomized Controlled Trials as Topic
PubMed: 26228420
DOI: 10.1016/j.jpsychires.2015.07.005 -
European Psychiatry : the Journal of... Apr 2019Non-pharmacological interventions preferably precede pharmacological interventions in acute agitation. Reviews of pharmacological interventions remain descriptive or... (Meta-Analysis)
Meta-Analysis
INTRODUCTION
Non-pharmacological interventions preferably precede pharmacological interventions in acute agitation. Reviews of pharmacological interventions remain descriptive or compare only one compound with several other compounds. The goal of this study is to compute a systematic review and meta-analysis of the effect on restoring calmness after a pharmacological intervention, so a more precise recommendation is possible.
METHOD
A search in Pubmed and Embase was done to isolate RCT's considering pharmacological interventions in acute agitation. The outcome is reaching calmness within maximum of 2 h, assessed by the psychometric scales of PANSS-EC, CGI or ACES. Also the percentages of adverse effects was assessed.
RESULTS
Fifty-three papers were included for a systematic review and meta-analysis. Most frequent studied drug is olanzapine. Changes on PANNS-EC and ACES at 2 h showed the strongest changes for haloperidol plus promethazine, risperidon, olanzapine, droperidol and aripiprazole. However, incomplete data showed that the effect of risperidon is overestimated. Adverse effects are most prominent for haloperidol and haloperidol plus lorazepam.
CONCLUSION
Olanzapine, haloperidol plus promethazine or droperidol are most effective and safe for use as rapid tranquilisation. Midazolam sedates most quickly. But due to increased saturation problems, midazolam is restricted to use within an emergency department of a general hospital.
Topics: Aggression; Anti-Anxiety Agents; Antipsychotic Agents; Benzodiazepines; Drug Therapy, Combination; Haloperidol; Humans; Hypnotics and Sedatives; Lorazepam; Midazolam; Olanzapine; Promethazine; Psychomotor Agitation; Psychotic Disorders; Treatment Outcome
PubMed: 30721802
DOI: 10.1016/j.eurpsy.2019.01.014 -
Archives of Pediatrics & Adolescent... Sep 2008To perform a systematic review and meta-analysis to determine whether taking antiemetic drugs reduces vomiting and decreases the need for further intervention in... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
To perform a systematic review and meta-analysis to determine whether taking antiemetic drugs reduces vomiting and decreases the need for further intervention in children with gastroenteritis without causing significant adverse effects.
DATA SOURCES
Computerized databases, reference lists, and expert recommendations.
STUDY SELECTION
Prospective controlled trials evaluating medication use in children with vomiting from gastroenteritis.
INTERVENTION
Antiemetic drug therapy.
MAIN OUTCOME MEASURES
Emesis cessation, use of intravenous fluid for rehydration, hospital admission, return to care, and medication adverse effects.
RESULTS
The 11 articles that met the inclusion criteria evaluated various antiemetic agents: ondansetron (n = 6), domperidone (n = 2), trimethobenzamide (n = 2), pyrilamine-pentobarbital (n = 2), metoclopramide (n = 2), dexamethasone (n = 1), and promethazine (n = 1). Meta-analysis of 6 randomized, double-masked, placebo-controlled trials of ondansetron demonstrated decreased risk of further vomiting (5 studies; relative risk [RR], 0.45; 95% confidence interval [CI], 0.33-0.62; number needed to treat [NNT] = 5), reduced need for intravenous fluid (4 studies; RR, 0.41; 95% CI, 0.28-0.62; NNT = 5), and decreased risk of immediate hospital admission (5 studies; RR, 0.52; 95% CI, 0.27-0.95; NNT = 14). Diarrheal episodes increased in ondansetron-treated patients in 3 studies. Ondansetron use did not significantly affect return to care (5 studies; RR, 1.34; 95% CI, 0.77-2.35).
CONCLUSIONS
Ondansetron therapy decreases the risk of persistent vomiting, the use of intravenous fluid, and hospital admissions in children with vomiting due to gastroenteritis. Future treatment guidelines should incorporate ondansetron therapy for select children with gastroenteritis.
Topics: Acute Disease; Antiemetics; Child; Gastroenteritis; Humans; Vomiting
PubMed: 18762604
DOI: 10.1001/archpedi.162.9.858 -
Revista Brasileira de Psiquiatria (Sao... Sep 2009Rapid and safe tranquillisation is sometimes unavoidable. We conducted this systematic review to determine the value of the combination haloperidol plus promethazine,... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
Rapid and safe tranquillisation is sometimes unavoidable. We conducted this systematic review to determine the value of the combination haloperidol plus promethazine, frequently used in Brazil.
METHOD
We searched the Cochrane Schizophrenia Group's Register and included all randomised clinical trials involving aggressive people with psychosis for which haloperidol plus promethazine was being used. We reliably selected, quality assessed and extracted data from all relevant studies.
RESULTS
We identified four relevant high quality studies. The combination haloperidol plus promethazine mix was compared with midazolam, lorazepam, haloperidol alone and olanzapine Intramuscular. In Brazil, haloperidol plus promethazine was effective with over 2/3 of people being tranquil by 30 minutes, but midazolam was more swift and in India, compared with lorazepam, the combination was more effective. Over the next few hours reported differences are negligible. Haloperidol given without promethazine in this situation causes frequent serious adverse effects. Olanzapine is as rapidly tranquillising as haloperidol plus promethazine, but did not have an enduring effect and more people needed additional drugs within 4 hours.
CONCLUSION
All treatments evaluated are effective, but this review provides compelling evidence as to clear advantages of the haloperidol plus promethazine combination.
Topics: Anti-Anxiety Agents; Antipsychotic Agents; Benzodiazepines; Drug Therapy, Combination; Haloperidol; Humans; Lorazepam; Midazolam; Olanzapine; Promethazine; Psychomotor Agitation; Randomized Controlled Trials as Topic
PubMed: 19784494
DOI: 10.1590/s1516-44462009000300014 -
The Cochrane Database of Systematic... Nov 2016Health services often manage agitated or violent people, and such behaviour is particularly prevalent in emergency psychiatric services (10%). The drugs used in such... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Health services often manage agitated or violent people, and such behaviour is particularly prevalent in emergency psychiatric services (10%). The drugs used in such situations should ensure that the person becomes calm swiftly and safely.
OBJECTIVES
To examine whether haloperidol plus promethazine is an effective treatment for psychosis-induced aggression.
SEARCH METHODS
On 6 May 2015 we searched the Cochrane Schizophrenia Group's Register of Trials, which is compiled by systematic searches of major resources (including MEDLINE, EMBASE, AMED, BIOSIS, CINAHL, PsycINFO, PubMed, and registries of clinical trials) and their monthly updates, handsearches, grey literature, and conference proceedings.
SELECTION CRITERIA
All randomised clinical trials with useable data focusing on haloperidol plus promethazine for psychosis-induced aggression.
DATA COLLECTION AND ANALYSIS
We independently extracted data. For binary outcomes, we calculated risk ratio (RR) and its 95% confidence interval (CI), on an intention-to-treat basis. For continuous data, we estimated the mean difference (MD) between groups and its 95% CI. We employed a fixed-effect model for analyses. We assessed risk of bias for included studies and created 'Summary of findings' tables using GRADE.
MAIN RESULTS
We found two new randomised controlled trials (RCTs) from the 2015 update searching. The review now includes six studies, randomising 1367 participants and presenting data relevant to six comparisons.When haloperidol plus promethazine was compared with haloperidol alone for psychosis-induced aggression for the outcome not tranquil or asleep at 30 minutes, the combination treatment was clearly more effective (n=316, 1 RCT, RR 0.65, 95% CI 0.49 to 0.87, high-quality evidence). There were 10 occurrences of acute dystonia in the haloperidol alone arm and none in the combination group. The trial was stopped early as haloperidol alone was considered to be too toxic.When haloperidol plus promethazine was compared with olanzapine, high-quality data showed both approaches to be tranquillising. It was suggested that the combination of haloperidol plus promethazine was more effective, but the difference between the two approaches did not reach conventional levels of statistical significance (n=300, 1 RCT, RR 0.60, 95% CI 0.22 to 1.61, high-quality evidence). Lower-quality data suggested that the risk of unwanted excessive sedation was less with the combination approach (n=116, 2 RCTs, RR 0.67, 95% CI 0.12 to 3.84).When haloperidol plus promethazine was compared with ziprasidone all data were of lesser quality. We identified no binary data for the outcome tranquil or asleep. The average sedation score (Ramsay Sedation Scale) was lower for the combination approach but not to conventional levels of statistical significance (n=60, 1 RCT, MD -0.1, 95% CI - 0.58 to 0.38). These data were of low quality and it is unclear what they mean in clinical terms. The haloperidol plus promethazine combination appeared to cause less excessive sedation but again the difference did not reach conventional levels of statistical significance (n=111, 2 RCTs, RR 0.30, 95% CI 0.06 to 1.43).We found few data for the comparison of haloperidol plus promethazine versus haloperidol plus midazolam. Average Ramsay Sedation Scale scores suggest the combination of haloperidol plus midazolam to be the most sedating (n=60, 1 RCT, MD - 0.6, 95% CI -1.13 to -0.07, low-quality evidence). The risk of excessive sedation was considerably less with haloperidol plus promethazine (n=117, 2 RCTs, RR 0.12, 95% CI 0.03 to 0.49, low-quality evidence). Haloperidol plus promethazine seemed to decrease the risk of needing restraints by around 12 hours (n=60, 1 RCT, RR 0.24, 95% CI 0.10 to 0.55, low-quality evidence). It may be that use of midazolam with haloperidol sedates swiftly, but this effect does not last long.When haloperidol plus promethazine was compared with lorazepam, haloperidol plus promethazine seemed to more effectively cause sedation or tranquillisation by 30 minutes (n=200, 1 RCT, RR 0.26, 95% CI 0.10 to 0.68, high-quality evidence). The secondary outcome of needing restraints or seclusion by 12 hours was not clearly different between groups, with about 10% in each group needing this intrusive intervention (moderate-quality evidence). Sedation data were not reported, however, the combination group did have less 'any serious adverse event' in 24-hour follow-up, but there were not clear differences between the groups and we are unsure exactly what the adverse effect was. There were no deaths.When haloperidol plus promethazine was compared with midazolam, there was clear evidence that midazolam is more swiftly tranquillising of an aggressive situation than haloperidol plus promethazine (n=301, 1 RCT, RR 2.90, 95% CI 1.75 to 4.8, high-quality evidence). On its own, midazolam seems to be swift and effective in tranquillising people who are aggressive due to psychosis. There was no difference in risk of serious adverse event overall (n=301, 1 RCT, RR 1.01, 95% CI 0.06 to 15.95, high-quality evidence). However, 1 in 150 participants allocated haloperidol plus promethazine had a swiftly reversed seizure, and 1 in 151 given midazolam had swiftly reversed respiratory arrest.
AUTHORS' CONCLUSIONS
Haloperidol plus promethazine is effective and safe, and its use is based on good evidence. Benzodiazepines work, with midazolam being particularly swift, but both midazolam and lorazepam cause respiratory depression. Olanzapine intramuscular and ziprasidone intramuscular do seem to be viable options and their action is swift, but resumption of aggression with subsequent need to re-inject was more likely than with haloperidol plus promethazine. Haloperidol used on its own without something to offset its frequent and serious adverse effects does seem difficult to justify.
Topics: Aggression; Benzodiazepines; Drug Therapy, Combination; Haloperidol; Humans; Lorazepam; Midazolam; Promethazine; Psychomotor Agitation; Psychotic Disorders; Randomized Controlled Trials as Topic; Restraint, Physical
PubMed: 27885664
DOI: 10.1002/14651858.CD005146.pub3 -
The Cochrane Database of Systematic... Mar 2018Antipsychotic (neuroleptic) medication is used extensively to treat people with chronic mental illnesses. Its use, however, is associated with adverse effects, including... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Antipsychotic (neuroleptic) medication is used extensively to treat people with chronic mental illnesses. Its use, however, is associated with adverse effects, including movement disorders such as tardive dyskinesia (TD) - a problem often seen as repetitive involuntary movements around the mouth and face. This review, one in a series examining the treatment of TD, covers miscellaneous treatments not covered elsewhere.
OBJECTIVES
To determine whether drugs, hormone-, dietary-, or herb-supplements not covered in other Cochrane reviews on TD treatments, surgical interventions, electroconvulsive therapy, and mind-body therapies were effective and safe for people with antipsychotic-induced TD.
SEARCH METHODS
We searched the Cochrane Schizophrenia Group's Study-Based Register of Trials including trial registers (16 July 2015 and 26 April 2017), inspected references of all identified studies for further trials and contacted authors of trials for additional information.
SELECTION CRITERIA
We included reports if they were randomised controlled trials (RCTs) dealing with people with antipsychotic-induced TD and schizophrenia or other chronic mental illnesses who remained on their antipsychotic medication and had been randomly allocated to the interventions listed above versus placebo, no intervention, or any other intervention.
DATA COLLECTION AND ANALYSIS
We independently extracted data from these trials and we estimated risk ratios (RR) or mean differences (MD), with 95% confidence intervals (CIs). We assumed that people who left early had no improvement. We assessed risk of bias and created 'Summary of findings' tables using GRADE.
MAIN RESULTS
We included 31 RCTs of 24 interventions with 1278 participants; 22 of these trials were newly included in this 2017 update. Five trials are awaiting classification and seven trials are ongoing. All participants were adults with chronic psychiatric disorders, mostly schizophrenia, and antipsychotic-induced TD. Studies were primarily of short (three to six6 weeks) duration with small samples size (10 to 157 participants), and most (61%) were published more than 20 years ago. The overall risk of bias in these studies was unclear, mainly due to poor reporting of allocation concealment, generation of the sequence, and blinding.Nineteen of the 31 included studies reported on the primary outcome 'No clinically important improvement in TD symptoms'. Two studies found moderate-quality evidence of a benefit of the intervention compared with placebo: valbenazine (RR 0.63, 95% CI 0.46 to 0.86, 1 RCT, n = 92) and extract of Ginkgo biloba (RR 0.88, 95% CI 0.81 to 0.96, 1 RCT, n = 157), respectively. However, due to small sample sizes we cannot be certain of these effects.We consider the results for the remaining interventions to be inconclusive: Low- to very low-quality evidence of a benefit was found for buspirone (RR 0.53, 95% CI 0.33 to 0.84, 1 RCT, n = 42), dihydrogenated ergot alkaloids (RR 0.45, 95% CI 0.21 to 0.97, 1 RCT, n = 28), hypnosis or relaxation, (RR 0.45, 95% CI 0.21 to 0.94, 1 study, n = 15), pemoline (RR 0.48, 95% CI 0.29 to 0.77, 1 RCT, n = 46), promethazine (RR 0.24, 95% CI 0.11 to 0.55, 1 RCT, n = 34), insulin (RR 0.52, 95% CI 0.29 to 0.96, 1 RCT, n = 20), branched chain amino acids (RR 0.79, 95% CI 0.63 to 1.00, 1 RCT, n = 52), and isocarboxazid (RR 0.24, 95% CI 0.08 to 0.71, 1 RCT, n = 20). There was low- to very low-certainty evidence of no difference between intervention and placebo or no treatment for the following interventions: melatonin (RR 0.89, 95% CI 0.71 to 1.12, 2 RCTs, n = 32), lithium (RR 1.59, 95% CI 0.79 to 3.23, 1 RCT, n = 11), ritanserin (RR 1.00, 95% CI 0.70 to 1.43, 1 RCT, n = 10), selegiline (RR 1.37, 95% CI 0.96 to 1.94, 1 RCT, n = 33), oestrogen (RR 1.18, 95% CI 0.76 to 1.83, 1 RCT, n = 12), and gamma-linolenic acid (RR 1.00, 95% CI 0.69 to 1.45, 1 RCT, n = 16).None of the included studies reported on the other primary outcome, 'no clinically significant extrapyramidal adverse effects'.
AUTHORS' CONCLUSIONS
This review has found that the use of valbenazine or extract of Ginkgo biloba may be effective in relieving the symptoms of tardive dyskinesia. However, since only one RCT has investigated each one of these compounds, we are awaiting results from ongoing trials to confirm these results. Results for the remaining interventions covered in this review must be considered inconclusive and these compounds probably should only be used within the context of a well-designed evaluative study.
Topics: Adrenergic Uptake Inhibitors; Adult; Anti-Anxiety Agents; Antipsychotic Agents; Dihydroergotoxine; Dyskinesia, Drug-Induced; Ginkgo biloba; Humans; Hypnosis; Plant Extracts; Randomized Controlled Trials as Topic; Relaxation Therapy; Tetrabenazine; Valine
PubMed: 29552749
DOI: 10.1002/14651858.CD000208.pub2 -
Supportive Care in Cancer : Official... Apr 2008The goal of the study is to evaluate the effectiveness of four drug classes (opioids, phenothiazines, benzodiazepines, and systemic corticosteroids) for relieving... (Review)
Review
GOALS OF WORK
The goal of the study is to evaluate the effectiveness of four drug classes (opioids, phenothiazines, benzodiazepines, and systemic corticosteroids) for relieving dyspnea experienced by advanced cancer patients.
MATERIALS AND METHODS
A systematic literature review was conducted to July 2006. Search sources included MEDLINE, EMBASE, HealthSTAR, CINAHL, and the Cochrane Library. Four reviewers selected evidence using predefined criteria: controlled trials not limited to cancer and involving the specified drug classes for dyspnea treatment.
MAIN RESULTS
Three systematic reviews, one with meta-analysis, two practice guidelines, and 28 controlled trials were identified. Most examined the effect of opioids, generally morphine, on dyspnea. Although the results of individual trials were mixed, the systematic review with meta-analysis detected a significant benefit for dyspnea with systemic opioids; two small placebo-controlled trials in cancer patients found systemic morphine reduced dyspnea, and dihydrocodeine also significantly reduced dyspnea in four placebo-controlled trials. Nebulized morphine was not effective in controlling dyspnea in any study or the meta-analysis. No controlled trials examined systemic corticosteroids in the treatment of cancer patients, and of the other non-opioid drugs examined, only oral promethazine, a phenothiazine, showed some benefit in the relief of dyspnea. Studies varied in methodological quality.
CONCLUSIONS
Systemic opioids, administered orally or parenterally, can be used to manage dyspnea in cancer patients. Oral promethazine may also be used, as a second-line agent if systemic opioids cannot be used or in addition to systemic opioids. Nebulized morphine, prochlorperazine, and benzodiazepines are not recommended for the treatment of dyspnea, and promethazine must not be used parenterally.
Topics: Adrenal Cortex Hormones; Analgesics, Opioid; Benzodiazepines; Dyspnea; Humans; Neoplasms; Palliative Care; Phenothiazines; Quality of Life
PubMed: 18214551
DOI: 10.1007/s00520-007-0389-6 -
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