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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03486015
Other study ID # 186081
Secondary ID
Status Completed
Phase N/A
First received February 7, 2018
Last updated March 26, 2018
Start date March 1, 2016
Est. completion date April 10, 2017

Study information

Verified date March 2018
Source Region Örebro County
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date April 10, 2017
Est. primary completion date April 10, 2017
Accepts healthy volunteers No
Gender All
Age group 37 Weeks and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Region Örebro County

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
Primary 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.
Primary 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.
Primary 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.
Primary 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
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