Contact information
Type
Scientific
Primary contact
Dr Justus Byarugaba
ORCID ID
Contact details
Makerere Univeristy
Faculty of Medicine
Department of Pediatrics and Child Health
P.O. Box 7072
Kampala
-
Uganda
+256 75 696 633
byarugabaj@yahoo.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
FIC
Study hypothesis
The proportion of convulsions terminated by buccal midazolam is higher than the proportion of convulsions terminated by rectal diazepam in children.
Ethics approval
Ethics approved received from:
1. The Makerere University Medical School Research and Ethics Review Board (Uganda)
2. National Council of Science and Technology Institutional Review Board (IRB) (Uganda)
3. University of California San Francisco Institutional Review Board (IRB) (USA)
Study design
Randomised double blind clinical trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Prolonged convulsions
Intervention
Rectal diazepam versus buccal placebo
Intervention type
Drug
Phase
Not Specified
Drug names
Midazolam, diazepam
Primary outcome measures
Time taken to terminate convulsion within 10 minutes without re-occurence of the convulsion in an hour.
Secondary outcome measures
1. Time taken to re-occurence of convulsion after initial control
2. Time taken to terminate the convulsion within 10 minutes
3. Proportion of children who get respiratory depression within one hour after adminstration of the study drug
Overall trial start date
20/11/2005
Overall trial end date
20/05/2006
Reason abandoned
Eligibility
Participant inclusion criteria
1. Age between 3 months to 12 years
2. Admission to Acute Care Unit during the study period
3. A child who presents to the Acute Care Unit with convulsions
4. Provision of informed consent to continue participation in the study
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
350
Participant exclusion criteria
1. Documented evidence of having recieved parenteral anticonvulsant in the past 24 hours
2. Cessation of convulsion before adminstration of study drug
3. Parent/caretaker verbally declines to participate in the study
Recruitment start date
20/11/2005
Recruitment end date
20/05/2006
Locations
Countries of recruitment
Uganda
Trial participating centre
Makerere Univeristy
Kampala
-
Uganda
Sponsor information
Organisation
Fogarty International Center (FIC) (USA)
Sponsor details
National Institutes of Health
Office of Communications
Building 31
Room B2C29
31 Center Drive
MSC 2220
Bethesda
20892-2220
United States of America
+1 301 496 2075
ficinfo@nih.gov
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Fogarty International Centre (FIC) (USA) (grant ref: TW007375)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
Results in http://www.ncbi.nlm.nih.gov/pubmed/18166545
Publication citations
-
Results
Mpimbaza A, Ndeezi G, Staedke S, Rosenthal PJ, Byarugaba J, Comparison of buccal midazolam with rectal diazepam in the treatment of prolonged seizures in Ugandan children: a randomized clinical trial., Pediatrics, 2008, 121, 1, e58-64, doi: 10.1542/peds.2007-0930.