Midazolam Sedation for Neonatal Lumbar Puncture

Pain Clinical Trial

Official title:

Midazolam Sedation for Neonatal Lumbar Puncture in the Emergency Department: A Randomized Controlled Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00942539
• Other study ID #: 2958CTIL
• Status: Terminated
• Phase: Phase 2
• First received: July 18, 2009
• Last updated: May 5, 2014
• Start date: July 2009
• Est. completion date: July 2011

Study information

• Verified date: July 2010
• Source: Rambam Health Care Campus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 30 Days

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety
• Pain

Intervention

Drug:
• Midazolam
Intravenous infusion of 0.05 mg/kg of Midalolam

Locations

Country	Name	City	State
Israel	Rambam Health Care Campus	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Physician's level of satisfaction from the procedural conditions		Five minutes post successful LP	Yes
Secondary	LP Success rate		Five minutes post successful LP	Yes
Secondary	Adverse sedation reactions		During procedure and during recovery phase	Yes