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Completed

NCT Number: NCT03486015

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.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

37 week and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sterile water

Drug

2 ml of sterile water

30% Glucose

Drug

2 ml of 30% glucose

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Region Örebro County

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Apr 3, 2018
Registry last updated
Apr 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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