Percutaneous Pin Removal in Children - is Analgesia Necessary?
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01944085|
Recruitment Status : Completed
First Posted : September 17, 2013
Last Update Posted : September 17, 2013
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.
- 5-12 years of age
- 2 or 3 percutaneous pins in either elbow
- 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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||240 participants|
|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|
Active Comparator: Acetaminophen
Acetaminophen was administered 1 hour prior to pin removal (weight dependent dose)
Active Comparator: Ibuprofen
Ibuprofen was administered 1 hour prior to pin removal (weight dependent dose)
Other Name: Brufen
Placebo Comparator: Vitamin C (Placebo)
Vitamin C was administered 1 hour prior to pin removal (weight dependent dose)
Other: Vitamin C
Other Name: Ascorbic Acid
- Pain Score (0 -10) [ Time Frame: 10 minutes after pin removal ]Pain score is measured using the Wong-Baker Scale
- Pulse rate [ Time Frame: 10 minutes after pin removal ]Pulse rate is measured using a pulse oximeter (Nellcor Puritan Bennett - NPB-40)
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
|KK Women's & Children's Hospital|
|Singapore, Singapore, 229899|
|Principal Investigator:||Kevin Lim, MD, FRCS||KK Women's & Children's Hospital, SINGAPORE|