Midazolam Sedation for Neonatal Lumbar Puncture | NCT00942539

Studies
Midazolam Sedation for Neonatal Lumbar Puncture

NCT00942539

Sponsor

Rambam Health Care Campus

Status

Terminated

Last Update Posted

May 6, 2014Estimated

Enrollment

12Actual

Phase

Phase 2

Conditions

Pain
Anxiety

Interventions

Midazolam

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2010

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2009

Primary Completion Date

Jul 2011Actual

Completion Date

Jul 2011Actual

First Submitted Date

Jul 18, 2009

First Submission Date that Met QC Criteria

Jul 20, 2009

First Posted Date

Jul 21, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 5, 2014

Last Update Posted Date

May 6, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

i_shavit, Pediatric Emergency Department director, Rambam Health Care CampusPrincipal Investigator

Lead Sponsor

Rambam Health Care CampusOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Midazolam	Experimental	Administration of Midazolam prior Lumbar Puncture	Drug: Midazolam

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Midazolam	Drug	Intravenous infusion of 0.05 mg/kg of Midalolam	Midazolam

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Days

Maximum Age

30 Days

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Itai Shavit, MD	Rambam Health Care Campus	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rambam Health Care Campus		Haifa			Israel

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain
D001008	Anxiety Disorders

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008874	Midazolam

Ancestor Terms

ID	Term
D001569	Benzodiazepines
D001552	Benzazepines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring

Browse Leaves

Not provided

Browse Branches

Not provided