Nasal Versus Venous Lorazepam for Control of Acute Seizures in Children (INLOR)

This study has been completed.
Sponsor:
Information provided by:
All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier:
NCT00735527
First received: August 12, 2008
Last updated: May 4, 2009
Last verified: May 2009

August 12, 2008
May 4, 2009
May 2008
April 2009   (final data collection date for primary outcome measure)
Cessation of all clinical seizure activity within 10 min of drug administration [ Time Frame: 10 min ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00735527 on ClinicalTrials.gov Archive Site
  • Persistent cessation of seizure activity for 1 hr [ Time Frame: 1 hr ] [ Designated as safety issue: No ]
  • Patients requiring rescue medication within 1 hr [ Time Frame: 1 hr ] [ Designated as safety issue: No ]
  • Time to achieve intra-venous access after arrival in casualty [ Time Frame: minutes ] [ Designated as safety issue: No ]
  • Time from drug administration to termination of seizure(s) [ Time Frame: minutes ] [ Designated as safety issue: No ]
  • Development of hypotension (fall of >/= 20 mmHg systolic and/ or >/= 10 mmHg diastolic pressure) within 1 hr of drug administration [ Time Frame: 1 hr ] [ Designated as safety issue: Yes ]
  • Development of significant respiratory depression requiring assisted ventilation [ Time Frame: 1 hr ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Nasal Versus Venous Lorazepam for Control of Acute Seizures in Children
Intra-Nasal vs. Intra-Venous Lorazepam for Control of Acute Seizures in Children: Prospective Open Labeled Randomized Equivalence Trial

Status epilepticus (SE) is a common pediatric emergency which is potentially life-threatening and requires rapid termination. Early and effective treatment is essential to prevent the morbidity and mortality associated with prolonged convulsive SE. Lorazepam is the standard of care for control of SE when administered by intra-venous (IV) route. The investigators intend to compare efficacy and adverse effect profile of intra-nasal vs. intravenous routes of administration of lorazepam. In resource poor settings, sometimes trained personnel or appropriate equipment for intra-venous cannulation is not available. Alternate routes of administration, if shown equivalent to conventional IV route, will be very useful in such settings or for out of hospital management of seizures in children.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Status Epilepticus
  • Seizures
  • Drug: Lorazepam
    Intra-nasal 0.1 mg/kg (maximum 4 mg) once
  • Drug: Lorazepam
    Intra-venous 0.1 mg/kg (maximum 4 mg) once
  • Experimental: 1
    Intra-nasal lorazepam 0.1 mg/kg (max 4 mg)
    Intervention: Drug: Lorazepam
  • Active Comparator: 2
    Intra-venous lorazepam 0.1 mg/kg (max 4 mg)
    Intervention: Drug: Lorazepam
Arya R, Gulati S, Kabra M, Sahu JK, Kalra V. Intranasal versus intravenous lorazepam for control of acute seizures in children: a randomized open-label study. Epilepsia. 2011 Apr;52(4):788-93. doi: 10.1111/j.1528-1167.2010.02949.x. Epub 2011 Jan 28.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
140
April 2009
April 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Children presenting convulsing to the pediatric emergency or developing seizure while in casualty
  • Age 6-14 years

Exclusion Criteria:

  • Known hypersensitivity to any benzodiazepine
  • Child has received any parenteral anti-convulsant within 1 hr prior to enrollment
  • Presence of severe cardio-respiratory compromise or cardiac arrhythmias
  • Presence of upper respiratory tract infection
  • Presence of basal skull fracture causing cerebro-spinal fluid (CSF) rhinorrhea
Both
6 Years to 14 Years
No
Contact information is only displayed when the study is recruiting subjects
India
 
NCT00735527
INLOR
Yes
Ravindra Arya, All India Institute of Medical Sciences
All India Institute of Medical Sciences, New Delhi
Not Provided
Not Provided
All India Institute of Medical Sciences, New Delhi
May 2009

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