Midazolam Sedation for Neonatal Lumbar Puncture

Phase 2

Terminated

• Conditions: Pain; Anxiety
• Interventions: Drug: Midazolam

• Registration Number: NCT00942539
• Lead Sponsor: Rambam Health Care Campus

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-07-18
• Study First Submitted QC: 2009-07-20
• Study First Posted: 2009-07-21
• Status Verified: 2010-07
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Last Update Submitted: 2014-05-05
• Last Update Posted: 2014-05-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Midazolam	Midazolam	Administration of Midazolam prior Lumbar Puncture

Primary Outcome Measures

Name	Time	Method
The Simplified Neonatal Facial Coding System will be used for assessment of pain. Scoring will be composed from four specific facial actions (brow bulge, nasolabial furrow, eye squeeze, and open mouth) and the presence or absence of crying	20 seconds prior lumbar puncture, during needle insertion, and 20 seconds post insertion

Secondary Outcome Measures

Name	Time	Method
Physician's level of satisfaction from the procedural conditions	Five minutes post successful LP
LP Success rate	Five minutes post successful LP
Adverse sedation reactions	During procedure and during recovery phase

Trial Locations

Locations (1)

Rambam Health Care Campus; 🇮🇱 Haifa, Israel