Pain Clinical Trial
Official title:
Oral Sweet Solution to Prevent Pain During Neonatal Hip Examination
Verified date | March 2018 |
Source | Region Örebro County |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study evaluates the pain relieving effect of oral glucose during hip examinations on healthy, fullterm infants.
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
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Region Örebro County |
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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