NCT01944085

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 17, 2013

Completed
Last Updated

September 17, 2013

Status Verified

September 1, 2013

Enrollment Period

3.2 years

First QC Date

September 12, 2013

Last Update Submit

September 12, 2013

Conditions

Elbow Fracture

Keywords

childrensupracondylar fracturepin removalanalgesiapain score

Outcome Measures

Primary Outcomes (1)

  • Pain Score (0 -10)

    Pain score is measured using the Wong-Baker Scale

    10 minutes after pin removal

Secondary Outcomes (1)

  • Pulse rate

    10 minutes after pin removal

Study Arms (3)

Acetaminophen

ACTIVE COMPARATOR

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

Drug: Acetaminophen

Ibuprofen

ACTIVE COMPARATOR

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

Drug: Ibuprofen

Vitamin C (Placebo)

PLACEBO COMPARATOR

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

Other: Vitamin C

Interventions

AcetaminophenDRUG

Syrup

Also known as: Paracetamol, Tylenol
Acetaminophen
IbuprofenDRUG

Syrup

Also known as: Brufen
Ibuprofen
Vitamin COTHER

Syrup

Also known as: Ascorbic Acid
Vitamin C (Placebo)

Eligibility Criteria

Age5 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • documented or suspected allergies to acetaminophen or ibuprofen

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KK Women's & Children's Hospital

Singapore, Singapore, 229899, Singapore

Location

Related Publications (2)

  • 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.

    PMID: 23255649BACKGROUND

  • 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.

    PMID: 24695927DERIVED

MeSH Terms

Conditions

Elbow FracturesAgnosia

Interventions

AcetaminophenIbuprofenAscorbic Acid

Condition Hierarchy (Ancestors)

Elbow InjuriesArm InjuriesWounds and InjuriesFractures, BonePerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesPhenylpropionatesAcids, CarbocyclicCarboxylic AcidsSugar AcidsAcids, AcyclicHydroxy AcidsCarbohydrates

Study Officials

  • Kevin Lim, MD, FRCS

    KK Women's & Children's Hospital, SINGAPORE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2013

First Posted

September 17, 2013

Study Start

October 1, 2008

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

September 17, 2013

Record last verified: 2013-09

Locations

SG(1)