Analgesic Properties of Oral Sucrose During Immunizations

NCT00446875 | Completed DMC

• 1 other identifier: SeedHatfield
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to examine the analgesic properties of oral sucrose during routine immunizations. Hypothesis: Oral sucrose solution and maternal contact will significantly decrease the objective measures of acute pain during routine immunizations.

Conditions

Procedural Pain

Keywords

Pain; Procedural pain; Sucrose; Infant

Outcome Measures

Primary Outcomes (1)

• Behavioral pain response

  Infants will be evaluated based on the University of Wisconsin Children's Hospital Pain Scale to score an infant's pain. Possible scores range from 0 (no pain) to 5 (worst possible pain).

  Baseline, and then at 2 and 5 minutes post DTaP, IPV, and Hep B vaccine

Study Arms (2)

Sucrose

EXPERIMENTAL

Participants received oral sucrose (0.6mL/Kg) 2 minutes prior to the combind DTaP, IPV, and Hep B (Hib and PCV7) vaccine.

Other: Administration of oral Sucrose

Placebo

PLACEBO COMPARATOR

Participants received Placebo (sterile water, 0.6mL/Kg) 2 minutes prior to the combind DTaP, IPV, and Hep B (Hib and PCV7) vaccine.

Other: Administration of oral Placebo

Interventions

Administration of oral Sucrose OTHER

Participants received oral sucrose 2 minutes prior to the combind DTaP, IPV, and Hep B vaccine.

Sucrose

Administration of oral Placebo OTHER

Participants received Placebo 2 minutes prior to the combind DTaP, IPV, and Hep B vaccine.

Also known as: sterile water

Placebo

Eligibility Criteria

• Age: 3 Months - 11 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Currently between 4 and 11 months of age;
• Between 37 and 42 weeks' completed gestation at birth;
• Birth weight greater than 2.5 kg; and
• No evidence of acute or chronic disease

You may not qualify if:

• Fed 30 minutes prior to immunization;
• Received analgesic/sedative the day of the immunizations;
• Parent wishes to feed the infant during the immunizations;
• Infant is diagnosed with a major congenital disorder where the behavioral responses to painful stimuli may be altered; or
• Language barriers preclude the process of obtaining parental consent.

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

University Pediatric Associates, Penn State Children's Hospital

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Pain, Procedural; Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Linda A Hatfield, PhD

  The Penn State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double Blind (subject, Investigator)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2007
• First Posted: March 13, 2007
• Study Start: January 1, 2007
• Primary Completion: May 19, 2008
• Study Completion: May 19, 2008
• Last Updated: February 15, 2019

Record last verified: 2019-02

Locations

US (1)