Pain
Conditions
Brief summary
This study evaluates the pain relieving effect of oral glucose during hip examinations on healthy, fullterm infants.
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
DRUGSterile water
2 ml of sterile water
DRUG30% glucose
2 ml of 30% glucose
Sponsors
Region Örebro County
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
37 Weeks to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 | 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 | 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 | 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 | 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. |
Outcome results
None listed