Midazolam Sedation for Neonatal Lumbar Puncture

• Status: Terminated
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rambam Health Care Campus
• Treatments: Midazolam

Criteria

Inclusion Criteria:

• American Society of Anesthesiologists (ASA) score I, II

• Post natal age ≤ 30 days

• Fasting of at least 2 hours before the procedure

Exclusion Criteria:

• American Society of Anesthesiologists (ASA) score III or greater

• Gestational age of 37 weeks or younger

• Congenital disease or defect

• Any medication provided by the caregiver prior ED admission

• Fasting of less than 2 hours