Oral Sweet Solution to Prevent Pain During Neonatal Hip Examination

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-01

Study Completion Date

2017-04-10

Brief Summary

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This study evaluates the pain relieving effect of oral glucose during hip examinations on healthy, fullterm infants.

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Detailed Description

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All healthy, fullterm infants undergoes a medical examination after birth where 21 different components are assessed. One of the components is the hip examination which appears to be painful. Since painful experiences early in life can cause longterm negative effects it is important to treat pain during painful procedures.

One hundred healthy, fullterm infants were randomized to either glucose or sterile water orally before the routine medical examination before discharge from the maternity ward.

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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30% glucose

This group will be given 2 ml of 30% glucose in the mouth before the physical examination of the infant.

Group Type EXPERIMENTAL

30% glucose

Intervention Type DRUG

2 ml of 30% glucose

Sterile water

This group will be given 2 ml of sterile water in the mouth before the physical examination of the infant.

Group Type PLACEBO_COMPARATOR

Sterile water

Intervention Type DRUG

2 ml of sterile water

Interventions

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Sterile water

2 ml of sterile water

Intervention Type DRUG

30% glucose

2 ml of 30% glucose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy, fullterm infants that were undergoing a routine medical examination

Exclusion Criteria

* Prematurity
* Parents inability to speak Swedish well enough to give consent
* Congenital malformations or other illnesses
* Any pain-relieving medicine administered in the previous 24 hours

Minimum Eligible Age

37 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No