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Percutaneous Pin Removal in Children - is Analgesia Necessary?

NCT ID: NCT01944085

Last Updated: 2013-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2011-12-31

Brief Summary

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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

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See Brief Summary

Conditions

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Elbow Fracture

Keywords

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children supracondylar fracture pin removal analgesia pain score

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Acetaminophen

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

Group Type ACTIVE_COMPARATOR

Acetaminophen

Intervention Type DRUG

Syrup

Ibuprofen

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

Group Type ACTIVE_COMPARATOR

Ibuprofen

Intervention Type DRUG

Syrup

Vitamin C (Placebo)

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

Group Type PLACEBO_COMPARATOR

Vitamin C

Intervention Type OTHER

Syrup

Interventions

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Acetaminophen

Syrup

Intervention Type DRUG

Ibuprofen

Syrup

Intervention Type DRUG

Vitamin C

Syrup

Intervention Type OTHER

Other Intervention Names

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Paracetamol Tylenol Brufen Ascorbic Acid

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* documented or suspected allergies to acetaminophen or ibuprofen
Minimum Eligible Age

5 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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KK Women's and Children's Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kevin Lim, MD, FRCS

Role: PRINCIPAL_INVESTIGATOR

KK Women's & Children's Hospital, SINGAPORE

Locations

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KK Women's & Children's Hospital

Singapore, Singapore, Singapore

Site Status

Countries

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Singapore

References

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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. doi: 10.1177/230949901202000322.

Reference Type BACKGROUND
PMID: 23255649 (View on PubMed)

Lim KB, Tan SS, Abdullah SN, Ong LL, Wong ML, Allen JC. Percutaneous pin removal in the outpatient clinic--do children require analgesia?: a randomized controlled trial. J Bone Joint Surg Am. 2014 Apr 2;96(7):597-602. doi: 10.2106/JBJS.M.00806.

Reference Type DERIVED
PMID: 24695927 (View on PubMed)

Other Identifiers

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percpinremoval

Identifier Type: -

Identifier Source: org_study_id