Analgesic Properties of Oral Sucrose During Immunizations

Not Applicable

Completed

• Conditions: Procedural Pain
• Interventions: Other: Administration of oral Placebo; Other: Administration of oral Sucrose

• Registration Number: NCT00446875
• Lead Sponsor: Milton S. Hershey Medical Center

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.

Detailed Description

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.

Acute pain during early life may alter infant pain responses, cognitive development and behavioral outcomes. Infants respond to immunizations with significant pain and distress. This study will examine the analgesic properties of oral sucrose and maternal holding in postnatal infants.

Comparison: Administration of oral sucrose, sterile water and maternal contact 2 minutes before routine immunizations.

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2007-03-09
• Study First Submitted QC: 2007-03-09
• Study First Posted: 2007-03-13
• Primary Completion: 2008-05-19
• Study Completion: 2008-05-19
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-11
• Last Update Posted: 2019-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Administration of oral Placebo	Participants received Placebo (sterile water, 0.6mL/Kg) 2 minutes prior to the combind DTaP, IPV, and Hep B (Hib and PCV7) vaccine.
Sucrose	Administration of oral Sucrose	Participants received oral sucrose (0.6mL/Kg) 2 minutes prior to the combind DTaP, IPV, and Hep B (Hib and PCV7) vaccine.

Primary Outcome Measures

Name	Time	Method
Behavioral pain response	Baseline, and then at 2 and 5 minutes post DTaP, IPV, and Hep B vaccine	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).

Trial Locations

Locations (1)

University Pediatric Associates, Penn State Children's Hospital; 🇺🇸 Hershey, Pennsylvania, United States