Percutaneous Pin Removal in Children - is Analgesia Necessary?

Not Applicable

Completed

• Conditions: Elbow Fracture
• Interventions: Drug: Acetaminophen; Drug: Ibuprofen; Other: Vitamin C

• Registration Number: NCT01944085
• Lead Sponsor: KK Women's and Children's Hospital

Brief Summary

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

See Brief Summary

Study Timeline

• Study Start: 2008-10
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2013-09
• Study First Submitted: 2013-09-12
• Study First Submitted QC: 2013-09-12
• Last Update Submitted: 2013-09-12
• Study First Posted: 2013-09-17
• Last Update Posted: 2013-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

• age: 5-12 inclusive
• 2 or 3 percutaneous pins in either elbow

Exclusion Criteria

• documented or suspected allergies to acetaminophen or ibuprofen

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acetaminophen	Acetaminophen	Acetaminophen was administered 1 hour prior to pin removal (weight dependent dose)
Ibuprofen	Ibuprofen	Ibuprofen was administered 1 hour prior to pin removal (weight dependent dose)
Vitamin C (Placebo)	Vitamin C	Vitamin C was administered 1 hour prior to pin removal (weight dependent dose)

Primary Outcome Measures

Name	Time	Method
Pain Score (0 -10)	10 minutes after pin removal	Pain score is measured using the Wong-Baker Scale

Secondary Outcome Measures

Name	Time	Method
Pulse rate	10 minutes after pin removal	Pulse rate is measured using a pulse oximeter (Nellcor Puritan Bennett - NPB-40)

Trial Locations

Locations (1)

KK Women's & Children's Hospital; 🇸🇬 Singapore, Singapore