Percutaneous Pin Removal in Children - is Analgesia Necessary?

September 12, 2013 updated by: KK Women's and Children's Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

See Brief Summary

Study Type

Interventional

Enrollment (Actual)

240

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 229899
        • KK Women's & Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 12 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Acetaminophen
Acetaminophen was administered 1 hour prior to pin removal (weight dependent dose)
Drug: Acetaminophen
Syrup
Other Names:
  • Tylenol
  • Paracetamol
ACTIVE_COMPARATOR: Ibuprofen
Ibuprofen was administered 1 hour prior to pin removal (weight dependent dose)
Drug: Ibuprofen
Syrup
Other Names:
  • Brufen
PLACEBO_COMPARATOR: Vitamin C (Placebo)
Vitamin C was administered 1 hour prior to pin removal (weight dependent dose)
Other: Vitamin C
Syrup
Other Names:
  • Ascorbic Acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Score (0 -10)
Time Frame: 10 minutes after pin removal
Pain score is measured using the Wong-Baker Scale
10 minutes after pin removal

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pulse rate
Time Frame: 10 minutes after pin removal
Pulse rate is measured using a pulse oximeter (Nellcor Puritan Bennett - NPB-40)
10 minutes after pin removal

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

KK Women's and Children's Hospital

Investigators

  • Principal Investigator: Kevin Lim, MD, FRCS, KK Women's & Children's Hospital, Singapore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (ACTUAL)

December 1, 2011

Study Completion (ACTUAL)

December 1, 2011

Study Registration Dates

First Submitted

September 12, 2013

First Submitted That Met QC Criteria

September 12, 2013

First Posted (ESTIMATE)

September 17, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

September 17, 2013

Last Update Submitted That Met QC Criteria

September 12, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • percpinremoval

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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