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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00847028
• Other study ID #: HHmol-001
• Secondary ID: (EC NR 7/37/203)
• Status: Active, not recruiting
• Phase: N/A
• First received: February 17, 2009
• Last updated: February 17, 2009
• Start date: November 2007
• Est. completion date: April 2009

Study information

• Verified date: February 2009
• Source: Universiteit Antwerpen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 304
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Pain

Intervention

Other:
• glucose 10%
2 minutes prior to the venipuncture, a 10% glucose concentration was administered orally
• 20% glucose
2 minutes prior to the venipuncture, a 20% glucose concentration was administered orally
• glucose 30%
2 minutes prior to the venipuncture, a 30% glucose concentration was administered orally
• sterile water
2 minutes prior to the venipuncture, sterile water was administered orally

Locations

Country	Name	City	State
Belgium	H Hart ziekenhuis	Mol	Antwerp

Sponsors (1)

Lead Sponsor	Collaborator
Universiteit Antwerpen

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain after venipuncture measured by the Leuven pain scale for newborns		solution administration- waiting for 2 minutes-then venipuncture and immediate pain scoring	No
Secondary	difference in heart rhythm		heart rhythm measured before painful procedure - heart rythm after venipuncture compared to baseline measurement	No