Condition category
Infections and Infestations
Date applied
13/11/2005
Date assigned
02/12/2005
Last edited
18/03/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.fic.nih.gov/

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

  1. 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.

Additional files

Editorial Notes