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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

304 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2009-04-30

Brief Summary

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

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Detailed Description

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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).

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

glucose 10%

Group Type EXPERIMENTAL

glucose 10%

Intervention Type OTHER

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

2

glucose 20%

Group Type EXPERIMENTAL

20% glucose

Intervention Type OTHER

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

3

glucose 30%

Group Type EXPERIMENTAL

glucose 30%

Intervention Type OTHER

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

4

placebo: sterile water

Group Type PLACEBO_COMPARATOR

sterile water

Intervention Type OTHER

2 minutes prior to the venipuncture, sterile water was administered orally

Interventions

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glucose 10%

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

Intervention Type OTHER

20% glucose

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

Intervention Type OTHER

glucose 30%

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

Intervention Type OTHER

sterile water

2 minutes prior to the venipuncture, sterile water was administered orally

Intervention Type OTHER

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No