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

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

Study Overview

• Status: Unknown
• Conditions: Pain
• Intervention / Treatment: Other: glucose 10%; Other: 20% glucose; Other: glucose 30%; Other: sterile water

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 Type: Interventional
• Enrollment (Actual): 304
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Antwerp
    • Mol, Antwerp, Belgium, 2400
      • H Hart ziekenhuis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; glucose 10%	Other: glucose 10%; 2 minutes prior to the venipuncture, a 10% glucose concentration was administered orally
Experimental: 2; glucose 20%	Other: 20% glucose; 2 minutes prior to the venipuncture, a 20% glucose concentration was administered orally
Experimental: 3; glucose 30%	Other: glucose 30%; 2 minutes prior to the venipuncture, a 30% glucose concentration was administered orally
Placebo Comparator: 4; placebo: sterile water	Other: sterile water; 2 minutes prior to the venipuncture, sterile water was administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Universiteit Antwerpen
• Investigators: Principal Investigator: Ben Dilen, MSN, Universiteit Antwerpen + Heilig Hart ziekenhuis Mol

Study record dates

Study Major Dates

• Study Start: November 1, 2007
• Primary Completion (Anticipated): April 1, 2009
• Study Completion (Anticipated): April 1, 2009

Study Registration Dates

• First Submitted: February 17, 2009
• First Submitted That Met QC Criteria: February 17, 2009
• First Posted (Estimate): February 19, 2009

Study Record Updates

• Last Update Posted (Estimate): February 19, 2009
• Last Update Submitted That Met QC Criteria: February 17, 2009
• Last Verified: February 1, 2009

More Information

Terms related to this study

• Keywords: Pain; Newborn; venipuncture; glucose solution; non-pharmacologic pain relief.
• Other Study ID Numbers: HHmol-001; (EC NR 7/37/203).