Oral Sweet Solution to Prevent Pain During Neonatal Hip Examination

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

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.

Official Title
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Oral Sweet Solution to Prevent Pain During Neonatal Hip Examination

Conditions
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Pain

Intervention / Treatment
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* Drug: Sterile water
* Drug: 30% glucose


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 37 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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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 |