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

Universiteit Antwerpen304 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Enrollment

304

Conditions

Pain

Interventions

glucose 10%OTHER

2 minutes prior to the venipuncture, a 10% glucose concentration was administered orally

20% glucoseOTHER

2 minutes prior to the venipuncture, a 20% glucose concentration was administered orally

glucose 30%OTHER

2 minutes prior to the venipuncture, a 30% glucose concentration was administered orally

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (1)

H Hart ziekenhuis

Mol, Antwerp, Belgium

Outcomes

Primary Outcomes

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

difference in heart rhythm

Time frame: heart rhythm measured before painful procedure - heart rythm after venipuncture compared to baseline measurement

Data from ClinicalTrials.gov

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