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Midazolam Sedation for Neonatal Lumbar Puncture

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ClinicalTrials.gov Identifier: NCT00942539
Recruitment Status : Terminated
First Posted : July 21, 2009
Last Update Posted : May 6, 2014
Information provided by (Responsible Party):
i_shavit, 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.

Condition or disease Intervention/treatment Phase
Pain Anxiety Drug: Midazolam Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Midazolam Sedation for Neonatal Lumbar Puncture in the Emergency Department: A Randomized Controlled Trial
Study Start Date : July 2009
Primary Completion Date : July 2011
Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Midazolam
Administration of Midazolam prior Lumbar Puncture
Drug: Midazolam
Intravenous infusion of 0.05 mg/kg of Midalolam

Primary Outcome Measures :
  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 [ Time Frame: 20 seconds prior lumbar puncture, during needle insertion, and 20 seconds post insertion ]

Secondary Outcome Measures :
  1. Physician's level of satisfaction from the procedural conditions [ Time Frame: Five minutes post successful LP ]
  2. LP Success rate [ Time Frame: Five minutes post successful LP ]
  3. Adverse sedation reactions [ Time Frame: During procedure and during recovery phase ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 30 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00942539

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

Responsible Party: i_shavit, Pediatric Emergency Department director, Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT00942539     History of Changes
Other Study ID Numbers: 2958CTIL
First Posted: July 21, 2009    Key Record Dates
Last Update Posted: May 6, 2014
Last Verified: July 2010

Keywords provided by i_shavit, Rambam Health Care Campus:

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