Overview

This trial is active, not recruiting.

Condition pain
Treatments glucose 10%, 20% glucose, glucose 30%, sterile water
Sponsor Universiteit Antwerpen
Start date November 2007
End date April 2009
Trial size 304 participants
Trial identifier NCT00847028, (EC NR 7/37/203)., HHmol-001

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model factorial assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose supportive care
Arm
(Experimental)
glucose 10%
glucose 10%
2 minutes prior to the venipuncture, a 10% glucose concentration was administered orally
(Experimental)
glucose 20%
20% glucose
2 minutes prior to the venipuncture, a 20% glucose concentration was administered orally
(Experimental)
glucose 30%
glucose 30%
2 minutes prior to the venipuncture, a 30% glucose concentration was administered orally
(Placebo Comparator)
placebo: sterile water
sterile water
2 minutes prior to the venipuncture, sterile water was administered orally

Primary Outcomes

Measure
Pain after venipuncture measured by the Leuven pain scale for newborns
time frame: solution administration- waiting for 2 minutes-then venipuncture and immediate pain scoring

Secondary Outcomes

Measure
difference in heart rhythm
time frame: heart rhythm measured before painful procedure - heart rythm after venipuncture compared to baseline measurement

Eligibility Criteria

Male or female participants of any age.

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.

Additional Information

Official title Oral Glucose Solution as Pain Relief in Newborns: Results of a Clinical Trial
Principal investigator Ben Dilen, MSN
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).
Trial information was received from ClinicalTrials.gov and was last updated in February 2009.
Information provided to ClinicalTrials.gov by Universiteit Antwerpen.