Midazolam Sedation for Neonatal Lumbar Puncture

Rambam Health Care Campus

Status and phase: Terminated; Phase 2

Conditions: Anxiety; Pain

Treatments: Drug: Midazolam

Study type: Interventional

Funder types: Other

Identifiers

NCT00942539

2958CTIL

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 3 to 30 days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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12 participants in 1 patient group

Midazolam

Experimental group

Description:

Administration of Midazolam prior Lumbar Puncture

Treatment:

Drug: Midazolam