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Clinical Trials/NCT03486015
NCT03486015
Completed
Not Applicable

Oral Sweet Solution to Prevent Pain During Neonatal Hip Examination

Region Örebro County0 sites100 target enrollmentMarch 1, 2016

Overview

Phase
Not Applicable
Intervention
30% glucose
Conditions
Pain
Sponsor
Region Örebro County
Enrollment
100
Primary Endpoint
Pain will be measured with ALPS-Neo (Astrid Lindgren and Lund children's hospitals pain and stress assessment scale for preterm and sick newborn infants, range 0-10 where higher number means a higher intensity of rated pain) by a nurse
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

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

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2016
End Date
April 10, 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Region Örebro County
Responsible Party
Sponsor

Eligibility Criteria

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

Arms & Interventions

30% glucose

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

Intervention: 30% glucose

Sterile water

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

Intervention: Sterile water

Outcomes

Primary Outcomes

Pain will be measured with ALPS-Neo (Astrid Lindgren and Lund children's hospitals pain and stress assessment scale for preterm and sick newborn infants, range 0-10 where higher number means a higher intensity of rated pain) by a nurse

Time Frame: The assessment is made by the nurse when the physician starts with the hip examination, approximately 60 seconds after the study solution has been given.

Pain assessment instrument

Crying time during hip examination

Time Frame: The total crying time is measured from approximately 3 minutes from the study solution has been given until the hip examination has been completed (approx. during 30 sec up to 1 min) with the help of a stopwatch

The amount of time (in minutes) the infant is crying during the hip examination.

Total crying time will be measured

Time Frame: The total crying time is measured throughout the examination from zero minutes until approximately 10 minutes after the study solution has been given with the help of a stopwatch.

Total amount of time (in minutes) the infant is crying during the examination.

Pain will be measured by VAS (Visual analogue scale, range 0-10 where higher number means a higher intensity of rated pain) assessed by physician

Time Frame: The physician will make the VAS assessment directly after the physical examination is done, approximately 10 minutes after the study solution has been given.

Pain assessment instrument

Pain will be measured by VAS (Visual analogue scale, range 0-10 where higher number means a higher intensity of rated pain) assessed by parent

Time Frame: The parents will make the VAS assessment directly after the physical examination is done, approximately 10 minutes after the study solution has been given.

Pain assessment instrument

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