Comparison of buccal midazolam to rectal diazepam in the treatment of prolonged convulsions in children at Mulago Hospital
Abstract
Description
A dissertation submitted in partial fulfillment of the requirements for the award of the degree of Master of Medicine in Paediatrics and Child Health of Makerere University
INTRODUCTION: Convulsions continuing for five minutes or longer are common in children in sub-saharan Africa and are medical emergencies. We compared the efficancy and safety of rectal diazepam and buccal midazolam in the treatment of prolonged convuasions. OBJECTIVES: To evaluate the efficacy and safety of buccal midazolam as compared to rectal diazepam in the treatment of prolonged convulsions. METHODOLOGY: A single blind randomized clinical trial was conducted in the paediatric emergency unit in uganda’s national referral hospital. Consecutive patients aged 3 months to 12 years who presented with a convulsion of greater than five minuted were randomized to receive buccal midazolam (0.5mg/kg) plus rectal placebo or rectal diazepam (0.5mg/kg) plus buccal placebo. This study was registered and thetrial number is: (http://www.controlle-trials.com/ISRCTN13964268/Training+in+malaria+research+in+uganda). ANALYSIS: Data was analyzed using SPSS version 10.0 and STATA version 8.0. The Mann- Whitney test was used to compare medians, and the chi- square test to assess for the relative risk of failing treatment. Multivariate analysis using logistic regression was used to identify risk factors for treatment failure and recurrence of convulsions. ETHICS: Written consent to continue participation in the study was sought from the legal guardian after the child had received treatment. RESULTS: Data was analysed as intention to treat. Treatment failures occurred in 71 of 165 who received rectal diazepam (43.0%) compared to 50 of 165 who received buccal midazolam (30.3%; RR 1.42, 95% C1 1.06- 1.89, p= 0.016). The rate of respiratory depression was low and similar in the two treatment arms. CONCLUSIONS: Buccal midazolam was safe as and more effective than rectal diazepam for the treatment of convulsions in Ugandan children. RECOMMENDATIONS: Buccal midazolam should be considered as a potential alternative for rectal diazepam in the treatment of convulsions in Ugandan children.
MU-UCSF and Nuffield Foundation
INTRODUCTION: Convulsions continuing for five minutes or longer are common in children in sub-saharan Africa and are medical emergencies. We compared the efficancy and safety of rectal diazepam and buccal midazolam in the treatment of prolonged convuasions. OBJECTIVES: To evaluate the efficacy and safety of buccal midazolam as compared to rectal diazepam in the treatment of prolonged convulsions. METHODOLOGY: A single blind randomized clinical trial was conducted in the paediatric emergency unit in uganda’s national referral hospital. Consecutive patients aged 3 months to 12 years who presented with a convulsion of greater than five minuted were randomized to receive buccal midazolam (0.5mg/kg) plus rectal placebo or rectal diazepam (0.5mg/kg) plus buccal placebo. This study was registered and thetrial number is: (http://www.controlle-trials.com/ISRCTN13964268/Training+in+malaria+research+in+uganda). ANALYSIS: Data was analyzed using SPSS version 10.0 and STATA version 8.0. The Mann- Whitney test was used to compare medians, and the chi- square test to assess for the relative risk of failing treatment. Multivariate analysis using logistic regression was used to identify risk factors for treatment failure and recurrence of convulsions. ETHICS: Written consent to continue participation in the study was sought from the legal guardian after the child had received treatment. RESULTS: Data was analysed as intention to treat. Treatment failures occurred in 71 of 165 who received rectal diazepam (43.0%) compared to 50 of 165 who received buccal midazolam (30.3%; RR 1.42, 95% C1 1.06- 1.89, p= 0.016). The rate of respiratory depression was low and similar in the two treatment arms. CONCLUSIONS: Buccal midazolam was safe as and more effective than rectal diazepam for the treatment of convulsions in Ugandan children. RECOMMENDATIONS: Buccal midazolam should be considered as a potential alternative for rectal diazepam in the treatment of convulsions in Ugandan children.
MU-UCSF and Nuffield Foundation
Keywords
Buccal midazolam, Rectal diazepam, prolonged convulsions, children, Mulago Hospital, Sub-Saharan Africa