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.


Background: In sub-Saharan Africa, rectal diazepam or intramuscular paraldehyde are commonly used as first-line anticonvulsant agents in the emergency treatment of seizures in children. These treatments can be expensive and sometimes toxic. We aimed to assess a drug and delivery system that is potentially more effective, safer, and easier to administer than those presently in use.

Methods: We did an open randomised trial in a paediatric emergency department of a tertiary hospital in Malawi. 160 children aged over 2 months with seizures persisting for more than 5 min were randomly assigned to receive either intranasal lorazepam (100 microg/kg, n=80) or intramuscular paraldehyde (0.2 mL/kg, n=80). The primary outcome measure was whether the presenting seizure stopped with one dose of assigned anticonvulsant agent within 10 min of administration. The primary analysis was by intention-to-treat. This study is registered with ClinicalTrials.gov, number NCT00116064.

Findings: Intranasal lorazepam stopped convulsions within 10 min in 60 (75%) episodes treated (absolute risk 0.75, 95% CI 0.64-0.84), and intramuscular paraldehyde in 49 (61.3%; absolute risk 0.61, 95% CI 0.49-0.72). No clinically important cardiorespiratory events were seen in either group (95% binomial exact CI 0-4.5%), and all children finished the trial.

Interpretation: Intranasal lorazepam is effective, safe, and provides a less invasive alternative to intramuscular paraldehyde in children with protracted convulsions. The ease of use of this drug makes it an attractive and preferable prehospital treatment option.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Intranasal
  • Anticonvulsants / administration & dosage
  • Anticonvulsants / therapeutic use*
  • Child, Preschool
  • Emergency Service, Hospital / statistics & numerical data*
  • Female
  • HIV Infections / complications
  • Humans
  • Infant
  • Injections, Intramuscular
  • Lorazepam / administration & dosage
  • Lorazepam / therapeutic use*
  • Malawi
  • Male
  • Paraldehyde / administration & dosage
  • Paraldehyde / therapeutic use*
  • Seizures / drug therapy*
  • Seizures / etiology
  • Seizures / mortality
  • Treatment Outcome


  • Anticonvulsants
  • Lorazepam
  • Paraldehyde

Associated data

  • ClinicalTrials.gov/NCT00116064