NCT00116064

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
156

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jul 2004

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

June 26, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 27, 2005

Completed
Last Updated

July 21, 2006

Status Verified

June 1, 2005

First QC Date

June 26, 2005

Last Update Submit

July 20, 2006

Conditions

Status EpilepticusConvulsions

Keywords

intranasallorazepampaediatricconvulsions

Outcome Measures

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 (5)

  • 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

Interventions

intranasal lorazepamDRUG
intramuscular paraldehydeDRUG

Eligibility Criteria

Age2 Months - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Paediatric Emergency Department, Queen Elizabeth Central Hospital

Blantyre, Malawi

Location

Related Publications (1)

  • 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. doi: 10.1016/S0140-6736(06)68696-0.

    PMID: 16698412RESULT

MeSH Terms

Conditions

Status EpilepticusSeizures

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Elizabeth Molyneux, MRCPCH FFAEM

    Kamuzu University of Health Sciences

    STUDY DIRECTOR

  • Shafique Ahmad, MRCPCH FFAEM

    Kamuzu University of Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 26, 2005

First Posted

June 27, 2005

Study Start

July 1, 2004

Study Completion

June 1, 2005

Last Updated

July 21, 2006

Record last verified: 2005-06

Locations

MA(1)