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

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

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).

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

Conditions
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Pain

Intervention / Treatment
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* Other: glucose 10%
* Other: 20% glucose
* Other: glucose 30%
* Other: sterile water


Participation Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>glucose 10% | Other: glucose 10%<br>* 2 minutes prior to the venipuncture, a 10% glucose concentration was administered orally<br>|
| Experimental: 2<br>glucose 20% | Other: 20% glucose<br>* 2 minutes prior to the venipuncture, a 20% glucose concentration was administered orally<br>|
| Experimental: 3<br>glucose 30% | Other: glucose 30%<br>* 2 minutes prior to the venipuncture, a 30% glucose concentration was administered orally<br>|
| Placebo Comparator: 4<br>placebo: sterile water | Other: sterile water<br>* 2 minutes prior to the venipuncture, sterile water was administered orally<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain after venipuncture measured by the Leuven pain scale for newborns |  | solution administration- waiting for 2 minutes-then venipuncture and immediate pain scoring | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| difference in heart rhythm |  | heart rhythm measured before painful procedure - heart rythm after venipuncture compared to baseline measurement | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Newborn, Pain, glucose solution, venipuncture, non-pharmacologic pain relief.