Midazolam Sedation for Neonatal Lumbar Puncture

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2011-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Pain Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Midazolam

Administration of Midazolam prior Lumbar Puncture

Group Type EXPERIMENTAL

Midazolam

Intervention Type DRUG

Intravenous infusion of 0.05 mg/kg of Midalolam

Interventions

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Midazolam

Intravenous infusion of 0.05 mg/kg of Midalolam

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

3 Days

Maximum Eligible Age

30 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No