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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. The completion date has passed and the status has not been verified in more than two years.
Verified February 2009 by Universiteit Antwerpen.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00847028
First Posted: February 19, 2009
Last Update Posted: February 19, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Universiteit Antwerpen
  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
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Care Provider, 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:


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 ]

Secondary Outcome Measures:
  • difference in heart rhythm [ Time Frame: heart rhythm measured before painful procedure - heart rythm after venipuncture compared to baseline measurement ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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).
First Submitted: February 17, 2009
First Posted: February 19, 2009
Last Update Posted: February 19, 2009
Last Verified: February 2009

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

Additional relevant MeSH terms:
Pharmaceutical Solutions