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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00847028

Enrollment

304

Registered

2009-02-19

Start date

2007-11-30

Completion date

2009-04-30

Last updated

2009-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

Newborn, Pain, glucose solution, venipuncture, non-pharmacologic pain relief.

Brief summary

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

Detailed 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).

Interventions

OTHERglucose 10%

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

OTHER20% glucose

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

OTHERglucose 30%

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

OTHERsterile water

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

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

SUPPORTIVE_CARE

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Healthy volunteers

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.

Design outcomes

Primary

Measure	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

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

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026