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Completed

NCT Number: NCT00446875

Analgesic Properties of Oral Sucrose During Immunizations

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.

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Key information

Conditions

Procedural Pain Neurologic Manifestations Pain Pain, Procedural Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

3 month–11 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Pediatric Associates, Penn State Children's Hospital

Hershey, Pennsylvania, 17033, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Administration of oral Sucrose

Other

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

Administration of oral Placebo

Other

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

Other names: sterile water

Primary outcomes

  1. Behavioral pain response

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Milton S. Hershey Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Mar 13, 2007
Registry last updated
Feb 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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