Text Size

Midazolam Sedation for Neonatal Lumbar Puncture

This study has been terminated.
Sponsor:
Information provided by:
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT00942539
First received: July 18, 2009
Last updated: July 28, 2011
Last verified: July 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Pain
Anxiety
 Drug: Midazolam
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Midazolam Sedation for Neonatal Lumbar Puncture in the Emergency Department: A Randomized Controlled Trial

Resource links provided by NLM:

MedlinePlus related topics: Anxiety
U.S. FDA Resources

Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:
  • 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 [ Time Frame: 20 seconds prior lumbar puncture, during needle insertion, and 20 seconds post insertion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Physician's level of satisfaction from the procedural conditions [ Time Frame: Five minutes post successful LP ] [ Designated as safety issue: Yes ]
  • LP Success rate [ Time Frame: Five minutes post successful LP ] [ Designated as safety issue: Yes ]
  • Adverse sedation reactions [ Time Frame: During procedure and during recovery phase ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 28
Study Start Date: July 2009
Estimated Study Completion Date: July 2011
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Midazolam
Administration of Midazolam prior Lumbar Puncture
 Drug: Midazolam
Intravenous infusion of 0.05 mg/kg of Midalolam

  Eligibility

Ages Eligible for Study:   up to 30 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00942539

Locations
Israel
Rambam Health Care Campus
Haifa, Israel
Sponsors and Collaborators
Rambam Health Care Campus
Investigators
Principal Investigator: Itai Shavit, MD Rambam Health Care Campus
  More Information

No publications provided

Responsible Party: Principle investigator, Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT00942539     History of Changes
Other Study ID Numbers: 2958CTIL
Study First Received: July 18, 2009
Last Updated: July 28, 2011
Health Authority: Israel: Ministry of Health

Keywords provided by Rambam Health Care Campus:
Neonates

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders
Midazolam
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
 Physiological Effects of Drugs
Psychotropic Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013