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Completed

NCT Number: NCT01944085

Percutaneous Pin Removal in Children - is Analgesia Necessary?

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.

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Key information

Age range

5 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

KK Women's & Children's Hospital

Singapore, 229899

About this study

See Brief Summary

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • documented or suspected allergies to acetaminophen or ibuprofen

Treatment and study plan

Acetaminophen

Drug

Syrup

Other names: Paracetamol, Tylenol

Ibuprofen

Drug

Syrup

Other names: Brufen

Vitamin C

Other

Syrup

Other names: Ascorbic Acid

Primary outcomes

  1. Pain Score (0 -10)

    Time frame: 10 minutes after pin removal

    Pain score is measured using the Wong-Baker Scale

Secondary outcomes

  1. Pulse rate

    Time frame: 10 minutes after pin removal

    Pulse rate is measured using a pulse oximeter (Nellcor Puritan Bennett - NPB-40)

Sponsors and collaborators

Lead sponsor

KK Women's and Children's Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Sep 17, 2013
Registry last updated
Sep 17, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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