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

NCT00847028 | Unknown DMC

• 2 other identifiers: HHmol-001(EC NR 7/37/203).
• Study Type: interventional
• Target: 304
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pain

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Pain after venipuncture measured by the Leuven pain scale for newborns

  solution administration- waiting for 2 minutes-then venipuncture and immediate pain scoring

Secondary Outcomes (1)

• difference in heart rhythm

  heart rhythm measured before painful procedure - heart rythm after venipuncture compared to baseline measurement

Study Arms (4)

1

EXPERIMENTAL

glucose 10%

Other: glucose 10%

2

EXPERIMENTAL

glucose 20%

Other: 20% glucose

3

EXPERIMENTAL

glucose 30%

Other: glucose 30%

4

PLACEBO COMPARATOR

placebo: sterile water

Other: sterile water

Interventions

glucose 10% OTHER

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

1

20% glucose OTHER

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

2

glucose 30% OTHER

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

3

sterile water OTHER

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

4

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Neonates were included if they had to undergo a venipuncture as part of routine medical care.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universiteit Antwerpen: lead

Study Sites (1)

H Hart ziekenhuis

Mol, Antwerp, 2400, Belgium

Location

MeSH Terms

Conditions

Pain

Interventions

Glucose

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates

Study Officials

• Ben Dilen, MSN

  Universiteit Antwerpen + Heilig Hart ziekenhuis Mol

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 17, 2009
• First Posted: February 19, 2009
• Study Start: November 1, 2007
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: February 19, 2009

Record last verified: 2009-02

Locations

BE (1)