Oral Sweet Solution to Prevent Pain During Neonatal Hip Examination

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: April 10, 2017

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.

Interventions

  • Drug: Sterile water
    • 2 ml of sterile water
  • Drug: 30% glucose
    • 2 ml of 30% glucose

Arms, Groups and Cohorts

  • Experimental: 30% glucose
    • This group will be given 2 ml of 30% glucose in the mouth before the physical examination of the infant.
  • Placebo Comparator: Sterile water
    • This group will be given 2 ml of sterile water in the mouth before the physical examination of the infant.

Clinical Trial Outcome Measures

Primary Measures

  • 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
  • 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
  • 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.
  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 37 Weeks

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Region Örebro County
  • Provider of Information About this Clinical Study
    • Sponsor

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