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Intranasal Lorazepam Versus Intramuscular Paraldehyde in Paediatric Convulsions

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ClinicalTrials.gov Identifier: NCT00116064
Recruitment Status : Completed
First Posted : June 27, 2005
Last Update Posted : July 21, 2006
Information provided by:
University of Malawi College of Medicine

June 26, 2005
June 27, 2005
July 21, 2006
July 2004
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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
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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.
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Status Epilepticus
  • Convulsions
  • Drug: intranasal lorazepam
  • Drug: intramuscular paraldehyde
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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.
June 2005
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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
Sexes Eligible for Study: All
2 Months to 12 Years   (Child)
Contact information is only displayed when the study is recruiting subjects
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University of Malawi College of Medicine
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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