Analgesic Properties of Oral Sucrose During Immunizations

Penn State Health

Status: Completed

Conditions: Procedural Pain

Treatments: Other: Administration of oral Placebo; Other: Administration of oral Sucrose

Study type: Interventional

Funder types: Other

Identifiers

NCT00446875

SeedHatfield

Details and patient eligibility

About

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.

Full 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.

Enrollment: 98 patients

Sex: All

Ages: 3 to 11 months old

Volunteers: Accepts 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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98 participants in 2 patient groups, including a placebo group

Sucrose

Experimental group

Description:

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

Treatment:

Other: Administration of oral Sucrose

Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Administration of oral Placebo