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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01944085
• Other study ID #: percpinremoval
• Status: Completed
• Phase: N/A
• First received: September 12, 2013
• Last updated: September 12, 2013
• Start date: October 2008
• Est. completion date: December 2011

Study information

• Verified date: September 2013
• Source: KK Women's and Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Institutional Review Board
• Study type: Interventional

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.

Description:

See Brief Summary

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 12 Years

Eligibility

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

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

Intervention

Drug:
• Acetaminophen
Syrup
• Ibuprofen
Syrup

Other:
• Vitamin C
Syrup

Locations

Country	Name	City	State
Singapore	KK Women's & Children's Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
KK Women's and Children's Hospital

Country where clinical trial is conducted

Singapore, 

References & Publications (1)

Tay GT, Lokino ES, Ong LL, Abdullah SN, Wong ML, Lim KB. Pain during percutaneous pin removal in children with elbow fractures. J Orthop Surg (Hong Kong). 2012 Dec;20(3):369-70. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Score (0 -10)	Pain score is measured using the Wong-Baker Scale	10 minutes after pin removal	No
Secondary	Pulse rate	Pulse rate is measured using a pulse oximeter (Nellcor Puritan Bennett - NPB-40)	10 minutes after pin removal	No