Oral Sweet Solution to Prevent Pain During Neonatal Hip Examination

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

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: 30% glucose; Drug: Sterile water

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 months and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 30% glucose; This group will be given 2 ml of 30% glucose in the mouth before the physical examination of the infant.	Drug: 30% glucose; 2 ml of 30% glucose
Placebo Comparator: Sterile water; This group will be given 2 ml of sterile water in the mouth before the physical examination of the infant.	Drug: Sterile water; 2 ml of sterile water

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Pain assessment instrument	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 will be measured by VAS (Visual analogue scale, range 0-10 where higher number means a higher intensity of rated pain) assessed by physician	Pain assessment instrument	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 will be measured by VAS (Visual analogue scale, range 0-10 where higher number means a higher intensity of rated pain) assessed by parent	Pain assessment instrument	The parents will make the VAS assessment directly after the physical examination is done, approximately 10 minutes after the study solution has been given.
Total crying time will be measured	Total amount of time (in minutes) the infant is crying during the examination.	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.
Crying time during hip examination	The amount of time (in minutes) the infant is crying during the 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

Collaborators and Investigators

• Sponsor: Region Örebro County

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2016
• Primary Completion (Actual): April 10, 2017
• Study Completion (Actual): April 10, 2017

Study Registration Dates

• First Submitted: February 7, 2018
• First Submitted That Met QC Criteria: March 26, 2018
• First Posted (Actual): April 3, 2018

Study Record Updates

• Last Update Posted (Actual): April 3, 2018
• Last Update Submitted That Met QC Criteria: March 26, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 186081

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No