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

Universiteit Antwerpen

Status: Unknown

Conditions: Pain

Treatments: Other: sterile water; Other: 20% glucose; Other: glucose 30%; Other: glucose 10%

Study type: Interventional

Funder types: Other

Identifiers

NCT00847028

HHmol-001

(EC NR 7/37/203).

Details and patient eligibility

About

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

Full 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).

Enrollment: 304 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

---

304 participants in 4 patient groups, including a placebo group

1

Experimental group

Description:

glucose 10%

Treatment:

Other: glucose 10%

2

Experimental group

Description:

glucose 20%

Treatment:

Other: 20% glucose

3

Experimental group

Description:

glucose 30%

Treatment:

Other: glucose 30%

4

Placebo Comparator group

Description:

placebo: sterile water

Treatment:

Other: sterile water