Oral Sweet Solution to Prevent Pain During Neonatal Hip Examination

Not Applicable

Completed

• Conditions: Pain
• Interventions: Drug: 30% glucose; Drug: Sterile water

• Registration Number: NCT03486015
• Lead Sponsor: Region Örebro County

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.

Study Timeline

• Study Start: 2016-03-01
• Primary Completion: 2017-04-10
• Study Completion: 2017-04-10
• Study First Submitted: 2018-02-07
• Status Verified: 2018-03
• Study First Submitted QC: 2018-03-26
• Last Update Submitted: 2018-03-26
• Study First Posted: 2018-04-03
• Last Update Posted: 2018-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
30% glucose	30% glucose	This group will be given 2 ml of 30% glucose in the mouth before the physical examination of the infant.
Sterile water	Sterile water	This group will be given 2 ml of sterile water in the mouth before the physical examination of the infant.

Primary Outcome Measures

Name	Time	Method
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	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	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	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	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	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