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This study evaluates the pain relieving effect of oral glucose during hip examinations on healthy, fullterm infants.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 30% glucose | Experimental | This group will be given 2 ml of 30% glucose in the mouth before the physical examination of the infant. |
|
| Sterile water | Placebo Comparator | This group will be given 2 ml of sterile water in the mouth before the physical examination of the infant. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sterile water | Drug | 2 ml of sterile water |
| |
| 30% glucose |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D005947 | Glucose |
| ID | Term |
|---|---|
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 | Carbohydrates |
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| Drug |
2 ml of 30% glucose |
|