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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Universiteit Antwerpen.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Universiteit Antwerpen
ClinicalTrials.gov Identifier:
NCT00847028
First received: February 17, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted
  Purpose

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


Condition Intervention
Pain
 Other: glucose 10%
Other: 20% glucose
Other: glucose 30%
Other: sterile water

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Supportive Care
Official Title: Oral Glucose Solution as Pain Relief in Newborns: Results of a Clinical Trial

Resource links provided by NLM:

Drug Information available for: Dextrose
U.S. FDA Resources

Further study details as provided by Universiteit Antwerpen:

Primary Outcome Measures:
  • Pain after venipuncture measured by the Leuven pain scale for newborns [ Time Frame: solution administration- waiting for 2 minutes-then venipuncture and immediate pain scoring ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • difference in heart rhythm [ Time Frame: heart rhythm measured before painful procedure - heart rythm after venipuncture compared to baseline measurement ] [ Designated as safety issue: No ]

Enrollment: 304
Study Start Date: November 2007
Estimated Study Completion Date: April 2009
Estimated Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
glucose 10%
 Other: glucose 10%
2 minutes prior to the venipuncture, a 10% glucose concentration was administered orally
Experimental: 2
glucose 20%
 Other: 20% glucose
2 minutes prior to the venipuncture, a 20% glucose concentration was administered orally
Experimental: 3
glucose 30%
 Other: glucose 30%
2 minutes prior to the venipuncture, a 30% glucose concentration was administered orally
Placebo Comparator: 4
placebo: sterile water
 Other: sterile water
2 minutes prior to the venipuncture, sterile water was administered orally

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).

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00847028

Locations
Belgium
H Hart ziekenhuis
Mol, Antwerp, Belgium, 2400
Sponsors and Collaborators
Universiteit Antwerpen
Investigators
Principal Investigator: Ben Dilen, MSN Universiteit Antwerpen + Heilig Hart ziekenhuis Mol
  More Information

No publications provided

Responsible Party: Prof. Monique M. Elseviers, Nusing Sciences, University of Antwerp
ClinicalTrials.gov Identifier: NCT00847028     History of Changes
Other Study ID Numbers: HHmol-001, (EC NR 7/37/203).
Study First Received: February 17, 2009
Last Updated: February 17, 2009
Health Authority: Belgium: Institutional Review Board

Keywords provided by Universiteit Antwerpen:
Newborn
Pain
glucose solution
venipuncture
non-pharmacologic pain relief.

ClinicalTrials.gov processed this record on September 26, 2012