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Design
Randomised (allocation concealed*), blinded (outcome assessor was blinded to type of solution but not to the pacifier),* placebo controlled trial.
Setting
Maternity ward of a hospital in Poissy, France.
Patients
150 eligible newborns (59% boys) who had a 5 minute Apgar score
7, were medically stable, had not received naloxone during the previous 24 hours, and were not fed in the previous 30 minutes. 50 eligible newborns were not randomised because of non-availability of the observer (investigator).
Intervention
Infants were allocated to 1 of 6 groups with 25 infants each: no treatment, placebo (2 ml of sterile water), 2 ml of 30% glucose, 2 ml of 30% sucrose, a pacifier, and 2 ml of 30% sucrose and a pacifier. The solutions or pacifiers were given 2 minutes before venipuncture.
Main outcome measure
Pain during venipuncture and blood collection using the Douleur Aiguë du Nouveau-né (DAN) scale, a pain score (0=no pain, 10=maximum pain) based on
Douglas D McMillan, MD
Calgary Regional Health Authority Calgary, Alberta, Canada
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