Intranasal Lorazepam Versus Intramuscular Paraldehyde in Paediatric Convulsions

This study has been completed.
Sponsor:
Information provided by:
University of Malawi College of Medicine
ClinicalTrials.gov Identifier:
NCT00116064
First received: June 26, 2005
Last updated: July 20, 2006
Last verified: June 2005

June 26, 2005
July 20, 2006
July 2004
Not Provided
whether the presenting seizure stopped or not with a single dose of assigned anticonvulsant agent within 10 minutes of administration
Same as current
Complete list of historical versions of study NCT00116064 on ClinicalTrials.gov Archive Site
  • time from drug administration to cessation of convulsion
  • frequency of episodes requiring 2 or more anticonvulsant agents
  • continuous blood pressure and oxygen saturation for 30 minutes post drug administration
  • seizure recurrence within 24 hours of cessation of presenting convulsion
  • survival/death
Same as current
Not Provided
Not Provided
 
Intranasal Lorazepam Versus Intramuscular Paraldehyde in Paediatric Convulsions
A Randomised Trial to Compare the Efficacy and Safety of Intranasal Lorazepam and Intramuscular Paraldehyde in the Treatment of Convulsions in Children

The purpose of this study is to evaluate intranasal lorazepam in paediatric status epilepticus. This is a potentially, more effective, safer and cheaper treatment for a common paediatric medical emergency compared to our present first line therapy intramuscular paraldehyde.

The ideal first line anticonvulsant agent would be one that can be safely and easily given at a primary health care facility. It should be quick acting, have minimal cardiorespiratory side effects and have a relatively prolonged effect and be cheap. No combination of drug or delivery system fully satisfies these criteria. There are no large published studies evaluating intranasal lorazepam in paediatric status epilepticus. Given its favourable pharmacokinetics and potential practical advantages, we wished to assess the efficacy and safety of intranasal delivery of lorazepam compared to intramuscular paraldehyde, our existing first line anticonvulsant agent in the treatment of acute seizures in children.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Status Epilepticus
  • Convulsions
  • Drug: intranasal lorazepam
  • Drug: intramuscular paraldehyde
Not Provided
Ahmad S, Ellis JC, Kamwendo H, Molyneux E. Efficacy and safety of intranasal lorazepam versus intramuscular paraldehyde for protracted convulsions in children: an open randomised trial. Lancet. 2006 May 13;367(9522):1591-7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
156
June 2005
Not Provided

Inclusion Criteria:

  • Children aged between 2 months and 12 years
  • Presenting with generalised convulsions

Exclusion Criteria:

  • Any child who had received an anticonvulsant agent within 1 hour of presentation
  • Seizure stopped with rapid cooling or treatment of hypoglycaemia
  • Features consistent with organophosphate poisoning, hepatic or hypertensive encephalopathy
Both
2 Months to 12 Years
No
Contact information is only displayed when the study is recruiting subjects
Malawi
 
NCT00116064
P03/04/248
Not Provided
Not Provided
University of Malawi College of Medicine
Not Provided
Study Director: Elizabeth Molyneux, MRCPCH FFAEM College of Medicine, University of Malawi
Principal Investigator: Shafique Ahmad, MRCPCH FFAEM College of Medicine University of Malawi
University of Malawi College of Medicine
June 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP