NCT01944085

Percutaneous Pin Removal in Children - is Analgesia Necessary?

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 240 (actual)
• Sponsor: KK Women's and Children's Hospital · Other Government
• Sex: All
• Age: 5 Years – 12 Years
• Healthy volunteers: Not accepted

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

Conditions

• Elbow Fracture

Interventions

Type	Name	Description
DRUG	Acetaminophen	Syrup
DRUG	Ibuprofen	Syrup
OTHER	Vitamin C	Syrup

Timeline

• Start date: 2008-10-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2013-09-17
• Last updated: 2013-09-17

Locations

1 site across 1 country: Singapore