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This is a simple randomised clinical trial to study if non-narcotic analgesia reduces the pain score and pulse rate of children who undergo removal of percutaneous pins in the outpatient clinic.
Inclusion criteria:
Exclusion criteria:
- documented or suspected allergies to acetaminophen, ibuprofen
Patients enrolled in the study are instructed not take additional analgesia prior to the clinic visit (risk of overdosage explained). This is verified by clinic nurses conducting the trial.
At the clinic visit, they are randomized into one of three groups
1. acetaminophen; 2. ibuprofen; or 3. Vitamin C (Placebo).
They are served the 'medication' (weight-appropriate dose) and the pins are removed in the clinic an hour later.
Pain score (Wong-Baker scale) and pulse rate are measured before pin removal, immediately following pin removal, and 10 minutes after pin removal.
The study hypothesis is that non-narcotic analgesia (such as acetaminophen and ibuprofen) do not decrease pain score and pulse rate associated with the pin removal procedure.
See Brief Summary
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acetaminophen | Active Comparator | Acetaminophen was administered 1 hour prior to pin removal (weight dependent dose) |
|
| Ibuprofen | Active Comparator | Ibuprofen was administered 1 hour prior to pin removal (weight dependent dose) |
|
| Vitamin C (Placebo) | Placebo Comparator | Vitamin C was administered 1 hour prior to pin removal (weight dependent dose) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acetaminophen | Drug | Syrup |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Score (0 -10) | Pain score is measured using the Wong-Baker Scale | 10 minutes after pin removal |
| Measure | Description | Time Frame |
|---|---|---|
| Pulse rate | Pulse rate is measured using a pulse oximeter (Nellcor Puritan Bennett - NPB-40) | 10 minutes after pin removal |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kevin Lim, MD, FRCS | KK Women's & Children's Hospital, SINGAPORE | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KK Women's & Children's Hospital | Singapore | Singapore | 229899 | Singapore |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23255649 | Background | Tay GT, Lokino ES, Ong LL, Abdullah SN, Wong ML, Lim KB. Pain during percutaneous pin removal in children with elbow fractures. J Orthop Surg (Hong Kong). 2012 Dec;20(3):369-70. doi: 10.1177/230949901202000322. | |
| 24695927 | Derived | Lim KB, Tan SS, Abdullah SN, Ong LL, Wong ML, Allen JC. Percutaneous pin removal in the outpatient clinic--do children require analgesia?: a randomized controlled trial. J Bone Joint Surg Am. 2014 Apr 2;96(7):597-602. doi: 10.2106/JBJS.M.00806. |
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| ID | Term |
|---|---|
| D000092482 | Elbow Fractures |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D000092464 | Elbow Injuries |
| D001134 | Arm Injuries |
| D014947 | Wounds and Injuries |
| D050723 | Fractures, Bone |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| D007052 | Ibuprofen |
| D001205 | Ascorbic Acid |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Ibuprofen | Drug | Syrup |
|
|
| Vitamin C | Other | Syrup |
|
|
| D010468 |
| Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Aniline Compounds |
| D000588 | Amines |
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D006880 | Hydroxy Acids |
| D002241 | Carbohydrates |