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Percutaneous Pin Removal in Children - is Analgesia Necessary?

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ClinicalTrials.gov Identifier: NCT01944085
Recruitment Status : Completed
First Posted : September 17, 2013
Last Update Posted : September 17, 2013
Sponsor:
Information provided by (Responsible Party):
KK Women's and Children's Hospital

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.


Condition or disease Intervention/treatment Phase
Elbow Fracture Drug: Acetaminophen Drug: Ibuprofen Other: Vitamin C Not Applicable

Detailed Description:
See Brief Summary

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Percutaneous Pin Removal in the Outpatient Clinic - do Children Require Analgesia? A Randomized Controlled Trial
Study Start Date : October 2008
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011


Arm Intervention/treatment
Active Comparator: Acetaminophen
Acetaminophen was administered 1 hour prior to pin removal (weight dependent dose)
Drug: Acetaminophen
Syrup
Other Names:
  • Paracetamol
  • Tylenol

Active Comparator: Ibuprofen
Ibuprofen was administered 1 hour prior to pin removal (weight dependent dose)
Drug: Ibuprofen
Syrup
Other Name: Brufen

Placebo Comparator: Vitamin C (Placebo)
Vitamin C was administered 1 hour prior to pin removal (weight dependent dose)
Other: Vitamin C
Syrup
Other Name: Ascorbic Acid




Primary Outcome Measures :
  1. Pain Score (0 -10) [ Time Frame: 10 minutes after pin removal ]
    Pain score is measured using the Wong-Baker Scale


Secondary Outcome Measures :
  1. Pulse rate [ Time Frame: 10 minutes after pin removal ]
    Pulse rate is measured using a pulse oximeter (Nellcor Puritan Bennett - NPB-40)



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • documented or suspected allergies to acetaminophen or ibuprofen

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01944085


Locations
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Singapore
KK Women's & Children's Hospital
Singapore, Singapore, 229899
Sponsors and Collaborators
KK Women's and Children's Hospital
Investigators
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Principal Investigator: Kevin Lim, MD, FRCS KK Women's & Children's Hospital, SINGAPORE

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: KK Women's and Children's Hospital
ClinicalTrials.gov Identifier: NCT01944085    
Other Study ID Numbers: percpinremoval
First Posted: September 17, 2013    Key Record Dates
Last Update Posted: September 17, 2013
Last Verified: September 2013
Keywords provided by KK Women's and Children's Hospital:
children
supracondylar fracture
pin removal
analgesia
pain score
Additional relevant MeSH terms:
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Fractures, Bone
Wounds and Injuries
Acetaminophen
Vitamins
Ascorbic Acid
Ibuprofen
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antioxidants
Protective Agents