Analgesic Properties of Oral Sucrose During Immunizations

Procedural Pain Clinical Trial

Official title:

Efficacy of Oral Sucrose and Maternal Contact During Routine Immunizations in Postnatal Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00446875
• Other study ID #: SeedHatfield
• Status: Completed
• Phase: N/A
• Start date: January 2007
• Est. completion date: May 19, 2008

Study information

• Verified date: February 2019
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: May 19, 2008
• Est. primary completion date: May 19, 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Months to 11 Months

Eligibility

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.

Related Conditions & MeSH terms

• Procedural Pain

Intervention

Other:
• Administration of oral Sucrose
Participants received oral sucrose 2 minutes prior to the combind DTaP, IPV, and Hep B vaccine.
• Administration of oral Placebo
Participants received Placebo 2 minutes prior to the combind DTaP, IPV, and Hep B vaccine.

Locations

Country	Name	City	State
United States	University Pediatric Associates, Penn State Children's Hospital	Hershey	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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