Midazolam Sedation for Neonatal Lumbar Puncture

NCT00942539 | Terminated Phase 2

• 1 other identifier: 2958CTIL
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Anxiety

Keywords

Neonates

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (1)

Midazolam

EXPERIMENTAL

Administration of Midazolam prior Lumbar Puncture

Drug: Midazolam

Interventions

Midazolam DRUG

Intravenous infusion of 0.05 mg/kg of Midalolam

Midazolam

Eligibility Criteria

• Age: 3 Days - 30 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• American Society of Anesthesiologists (ASA) score I, II
• Post natal age ≤ 30 days
• Fasting of at least 2 hours before the procedure

You may not qualify if:

• 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

Sponsors & Collaborators

• Rambam Health Care Campus: lead

Study Sites (1)

Rambam Health Care Campus

Haifa, Israel

Location

MeSH Terms

Conditions

Pain; Anxiety Disorders

Interventions

Midazolam

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Itai Shavit, MD

  Rambam Health Care Campus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Emergency Department director

Study Record Dates

• First Submitted: July 18, 2009
• First Posted: July 21, 2009
• Study Start: July 1, 2009
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: May 6, 2014

Record last verified: 2010-07

Locations

IL (1)