Percutaneous Pin Removal in Children - is Analgesia Necessary?

KK Women's and Children's Hospital

Status: Completed

Conditions: Elbow Fracture

Treatments: Drug: Acetaminophen; Drug: Ibuprofen; Other: Vitamin C

Study type: Interventional

Funder types: Other

Identifiers

NCT01944085

percpinremoval

Details and patient eligibility

About

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.

Full description

See Brief Summary

Enrollment: 240 patients

Sex: All

Ages: 5 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• documented or suspected allergies to acetaminophen or ibuprofen

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

240 participants in 3 patient groups, including a placebo group

Acetaminophen

Active Comparator group

Description:

Acetaminophen was administered 1 hour prior to pin removal (weight dependent dose)

Treatment:

Drug: Acetaminophen

Ibuprofen

Active Comparator group

Description:

Ibuprofen was administered 1 hour prior to pin removal (weight dependent dose)

Treatment:

Drug: Ibuprofen

Vitamin C (Placebo)

Placebo Comparator group

Description:

Vitamin C was administered 1 hour prior to pin removal (weight dependent dose)

Treatment:

Other: Vitamin C