Percutaneous Pin Removal in Children - is Analgesia Necessary?

Study Overview
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Brief Summary
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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: 5-12 years of age 2 or 3 percutaneous pins in either elbow 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.

Detailed Description
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See Brief Summary

Official Title
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Percutaneous Pin Removal in the Outpatient Clinic - do Children Require Analgesia? A Randomized Controlled Trial

Conditions
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Elbow Fracture

Intervention / Treatment
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* Drug: Acetaminophen
* Drug: Ibuprofen
* Other: Vitamin C


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age: 5-12 inclusive 2 or 3 percutaneous pins in either elbow Exclusion Criteria: documented or suspected allergies to acetaminophen or ibuprofen

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Acetaminophen<br>Acetaminophen was administered 1 hour prior to pin removal (weight dependent dose) | Drug: Acetaminophen<br>* Syrup<br>* Other names: Tylenol;|
| Active Comparator: Ibuprofen<br>Ibuprofen was administered 1 hour prior to pin removal (weight dependent dose) | Drug: Ibuprofen<br>* Syrup<br>* Other names: Brufen;|
| Placebo Comparator: Vitamin C (Placebo)<br>Vitamin C was administered 1 hour prior to pin removal (weight dependent dose) | Other: Vitamin C<br>* Syrup<br>* Other names: Ascorbic Acid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Score (0 -10) | Pain score is measured using the Wong-Baker Scale | 10 minutes after pin removal | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulse rate | Pulse rate is measured using a pulse oximeter (Nellcor Puritan Bennett - NPB-40) | 10 minutes after pin removal | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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children, supracondylar fracture, pin removal, analgesia, pain score