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Analgesic Properties of Oral Sucrose During Immunizations

Primary Purpose

Procedural Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Administration of oral Sucrose
Administration of oral Placebo
Sponsored by
Milton S. Hershey Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Procedural Pain focused on measuring Pain, Procedural pain, Sucrose, Infant

Eligibility Criteria

3 Months - 11 Months (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University Pediatric Associates, Penn State Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Sucrose

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
March 9, 2007
Last Updated
February 11, 2019
Sponsor
Milton S. Hershey Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00446875
Brief Title
Analgesic Properties of Oral Sucrose During Immunizations
Official Title
Efficacy of Oral Sucrose and Maternal Contact During Routine Immunizations in Postnatal Infants
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
May 19, 2008 (Actual)
Study Completion Date
May 19, 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Milton S. Hershey Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Procedural Pain
Keywords
Pain, Procedural pain, Sucrose, Infant

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
Double Blind (subject, Investigator)
Allocation
Randomized
Enrollment
98 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sucrose
Arm Type
Experimental
Arm Description
Participants received oral sucrose (0.6mL/Kg) 2 minutes prior to the combind DTaP, IPV, and Hep B (Hib and PCV7) vaccine.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants received Placebo (sterile water, 0.6mL/Kg) 2 minutes prior to the combind DTaP, IPV, and Hep B (Hib and PCV7) vaccine.
Intervention Type
Other
Intervention Name(s)
Administration of oral Sucrose
Intervention Description
Participants received oral sucrose 2 minutes prior to the combind DTaP, IPV, and Hep B vaccine.
Intervention Type
Other
Intervention Name(s)
Administration of oral Placebo
Other Intervention Name(s)
sterile water
Intervention Description
Participants received Placebo 2 minutes prior to the combind DTaP, IPV, and Hep B vaccine.
Primary Outcome Measure Information:
Title
Behavioral pain response
Description
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).
Time Frame
Baseline, and then at 2 and 5 minutes post DTaP, IPV, and Hep B vaccine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
11 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Linda A Hatfield, PhD
Organizational Affiliation
The Penn State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Pediatric Associates, Penn State Children's Hospital
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States

12. IPD Sharing Statement

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Analgesic Properties of Oral Sucrose During Immunizations

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