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

Not Applicable

• Conditions: Pain
• Interventions: Other: glucose 10%; Other: 20% glucose; Other: glucose 30%; Other: sterile water

• Registration Number: NCT00847028
• Lead Sponsor: Universiteit Antwerpen

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).

Study Timeline

• Study Start: 2007-11
• Status Verified: 2009-02
• Study First Submitted: 2009-02-17
• Study First Submitted QC: 2009-02-17
• Last Update Submitted: 2009-02-17
• Study First Posted: 2009-02-19
• Last Update Posted: 2009-02-19
• Primary Completion: 2009-04
• Study Completion: 2009-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 304

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
1	glucose 10%	glucose 10%
2	20% glucose	glucose 20%
3	glucose 30%	glucose 30%
4	sterile water	placebo: sterile water

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
difference in heart rhythm	heart rhythm measured before painful procedure - heart rythm after venipuncture compared to baseline measurement

Trial Locations

Locations (1)

H Hart ziekenhuis; 🇧🇪 Mol, Antwerp, Belgium