Percutaneous Pin Removal in Children - is Analgesia Necessary?

Elbow Fracture Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial Description

See Brief Summary ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Elbow Fracture

• NCT number: NCT01944085
• Study type: Interventional
• Source: KK Women's and Children's Hospital
• Status: Completed
• Phase: N/A
• Start date: October 2008
• Completion date: December 2011