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Completed

NCT Number: NCT00116064

Intranasal Lorazepam Versus Intramuscular Paraldehyde in Paediatric Convulsions

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.

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Key information

Conditions

Status Epilepticus Convulsions Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Seizures Signs and Symptoms

Age range

2 month–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Paediatric Emergency Department, Queen Elizabeth Central Hospital

Blantyre, Malawi

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

intranasal lorazepam

Drug

intramuscular paraldehyde

Drug

Primary outcomes

  1. whether the presenting seizure stopped or not with a single dose of assigned anticonvulsant agent within 10 minutes of administration

Secondary outcomes

  1. time from drug administration to cessation of convulsion

  2. frequency of episodes requiring 2 or more anticonvulsant agents

  3. continuous blood pressure and oxygen saturation for 30 minutes post drug administration

  4. seizure recurrence within 24 hours of cessation of presenting convulsion

  5. survival/death

Sponsors and collaborators

Lead sponsor

Kamuzu University of Health Sciences

Other

Registry information

Official study title

A Randomised Trial to Compare the Efficacy and Safety of Intranasal Lorazepam and Intramuscular Paraldehyde in the Treatment of Convulsions in Children

Important dates

Study start
2004
Study completion
2005
First posted
Jun 27, 2005
Registry last updated
Jul 21, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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