Oral Glucose Solution as Pain Relief in Newborns: Results... | NCT00847028

Studies
Oral Glucose Solution as Pain Relief in Newborns: Results of a Clinical Trial

NCT00847028

Sponsor

Universiteit Antwerpen

Status

Unknown status

Last Update Posted

Feb 19, 2009Estimated

Enrollment

304Actual

Phase

Not Applicable

Conditions

Pain

Interventions

glucose 10%
20% glucose
glucose 30%
sterile water

Countries

Belgium

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

ID	Type	Description	Link
(EC NR 7/37/203).

Status Module

Record Verification Date

Feb 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2007

Primary Completion Date

Apr 2009Estimated

Completion Date

Apr 2009Estimated

First Submitted Date

Feb 17, 2009

First Submission Date that Met QC Criteria

Feb 17, 2009

First Posted Date

Feb 19, 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

Feb 17, 2009

Last Update Posted Date

Feb 19, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

This study investigates which concentration of glucose is most effective in reducing pain for venipuncture in the newborn.

Detailed Description

This double-blind clinical trial is conducted on a maternity and newborn (N*) ward. Each time, during at least one month, one of the four selected solutions (glucose 10%, 20%, 30% and placebo) will be administered orally, 2 minutes prior to the venipuncture. The pain from the skin puncture will be scored using a validated pain scale (the "Leuven" pain scale).

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

304Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	glucose 10%	Other: glucose 10%
2	Experimental	glucose 20%	Other: 20% glucose
3	Experimental	glucose 30%	Other: glucose 30%
4	Placebo Comparator	placebo: sterile water	Other: sterile water

Interventions

Name	Type	Description	Arm Group Labels	Other Names
glucose 10%	Other	2 minutes prior to the venipuncture, a 10% glucose concentration was administered orally	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain after venipuncture measured by the Leuven pain scale for newborns		solution administration- waiting for 2 minutes-then venipuncture and immediate pain scoring

Secondary Outcomes

Measure	Description	Time Frame
difference in heart rhythm		heart rhythm measured before painful procedure - heart rythm after venipuncture compared to baseline measurement

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria

Neonates were included if they had to undergo a venipuncture as part of routine medical care.

Exclusion criteria

Unstable neonates with respiratory support as well as neonates with a proven neurological abnormality were excluded.
Newborns who had been administered sedatives, analgesics or naloxone during the past 48 hours were excluded along with premature infants younger than 32 weeks post menstrual age.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ben Dilen, MSN	Universiteit Antwerpen + Heilig Hart ziekenhuis Mol	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
H Hart ziekenhuis		Mol	Antwerp	2400	Belgium

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D005947	Glucose

Ancestor Terms

ID	Term
D006601	Hexoses
D009005	Monosaccharides
D000073893	Sugars
D002241	Carbohydrates

Browse Leaves

Not provided

Browse Branches

Not provided