NCT00942539

Midazolam Sedation for Neonatal Lumbar Puncture

Midazolam Sedation for Neonatal Lumbar Puncture in the Emergency Department: A Randomized Controlled Trial

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Rambam Health Care Campus · Academic / Other
• Sex: All
• Age: 3 Days – 30 Days
• Healthy volunteers: Not accepted

Summary

Lumbar puncture is one of the most common painful procedures performed on neonates in the Emergency Department (ED). The investigators will study in a randomized controlled trial, the efficacy of intravenous administration of a single dose of Midazolam in reducing pain and anxiety in neonates undergoing lumbar puncture in the ED, as well as the rate of adverse sedation reactions. The investigators hypothesize that compared with placebo, single dose Midazolam would significantly decrease pain and anxiety and will have low rate of adverse reactions.

Conditions

• Pain
• Anxiety

Interventions

Type	Name	Description
DRUG	Midazolam	Intravenous infusion of 0.05 mg/kg of Midalolam

Timeline

• Start date: 2009-07-01
• Primary completion: 2011-07-01
• Completion: 2011-07-01
• First posted: 2009-07-21
• Last updated: 2014-05-06

Locations

1 site across 1 country: Israel