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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01944085
Enrollment
240
Registered
2013-09-17
Start date
2008-10-31
Completion date
2011-12-31
Last updated
2013-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Elbow Fracture

Keywords

children, supracondylar fracture, pin removal, analgesia, pain score

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

Interventions

DRUGAcetaminophen

Syrup

DRUGIbuprofen

Syrup

OTHERVitamin C

Syrup

Sponsors

KK Women's and Children's Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
5 Years to 12 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* documented or suspected allergies to acetaminophen or ibuprofen

Design outcomes

Primary

MeasureTime frameDescription
Pain Score (0 -10)10 minutes after pin removalPain score is measured using the Wong-Baker Scale

Secondary

MeasureTime frameDescription
Pulse rate10 minutes after pin removalPulse rate is measured using a pulse oximeter (Nellcor Puritan Bennett - NPB-40)

Countries

Singapore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026