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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

February 17, 2009
February 17, 2009
November 2007
April 2009   (final data collection date for primary outcome measure)
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 ]
Same as current
No Changes Posted
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 ]
Same as current
Not Provided
Not Provided
 
Oral Glucose Solution as Pain Relief in Newborns: Results of a Clinical Trial
Oral Glucose Solution as Pain Relief in Newborns: Results of a Clinical Trial

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

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).

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Supportive Care
Pain
  • Other: glucose 10%
    2 minutes prior to the venipuncture, a 10% glucose concentration was administered orally
  • Other: 20% glucose
    2 minutes prior to the venipuncture, a 20% glucose concentration was administered orally
  • Other: glucose 30%
    2 minutes prior to the venipuncture, a 30% glucose concentration was administered orally
  • Other: sterile water
    2 minutes prior to the venipuncture, sterile water was administered orally
  • Experimental: 1
    glucose 10%
    Intervention: Other: glucose 10%
  • Experimental: 2
    glucose 20%
    Intervention: Other: 20% glucose
  • Experimental: 3
    glucose 30%
    Intervention: Other: glucose 30%
  • Placebo Comparator: 4
    placebo: sterile water
    Intervention: Other: sterile water
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
304
April 2009
April 2009   (final data collection date for primary outcome measure)

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.
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT00847028
HHmol-001, (EC NR 7/37/203).
Yes
Prof. Monique M. Elseviers, Nusing Sciences, University of Antwerp
Universiteit Antwerpen
Not Provided
Principal Investigator: Ben Dilen, MSN Universiteit Antwerpen + Heilig Hart ziekenhuis Mol
Universiteit Antwerpen
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP