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Percutaneous Pin Removal in Children - is Analgesia Necessary?

NCT01944085 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2013-09-17

No results posted yet for this study

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.

Conditions

  • Elbow Fracture

Interventions

DRUG

Acetaminophen

Syrup

DRUG

Ibuprofen

Syrup

OTHER

Vitamin C

Syrup

Sponsors & Collaborators

  • KK Women's and Children's Hospital

    lead OTHER_GOV

Principal Investigators

  • Kevin Lim, MD, FRCS · KK Women's & Children's Hospital, SINGAPORE

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • Singapore

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01944085 on ClinicalTrials.gov