Elbow FractureNCT01944085
Percutaneous Pin Removal in Children - is Analgesia Necessary?
A study testing Acetaminophen, Ibuprofen and Vitamin C in people with Elbow Fracture, run by KK Women's and Children's Hospital at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Elbow Fracture
- What is being tested?
- Acetaminophen, Ibuprofen and Vitamin C
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteSingapore
- Study dates
- Oct 2008to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- age: 5-12 inclusive
- 2 or 3 percutaneous pins in either elbow
Who cannot join
- documented or suspected allergies to acetaminophen or ibuprofen
Trial locations and contacts
1 site in 1 country.
Singapore1 site
KK Women's & Children's Hospital
Singapore, Singapore, 229899
About this study
Official title: Percutaneous Pin Removal in the Outpatient Clinic - do Children Require Analgesia? A Randomized Controlled Trial
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:
Read more
- 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
- 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.
Read the detailed description
See Brief Summary
- Conditions
- Elbow Fracture
- Being tested
- Acetaminophen, Ibuprofen, Vitamin C
- Keywords
- children, supracondylar fracture, pin removal, analgesia, pain score
- Medical subject headings
- Elbow Fractures, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcetaminophenDrug
Also called Paracetamol, Tylenol
Syrup
IbuprofenDrug
Also called Brufen
Syrup
Vitamin COther
Also called Ascorbic Acid
Syrup
| Study group | Role | What they receive |
|---|---|---|
| Acetaminophen | Active comparator | Acetaminophen was administered 1 hour prior to pin removal (weight dependent dose) Receives: Drug: Acetaminophen |
| Ibuprofen | Active comparator | Ibuprofen was administered 1 hour prior to pin removal (weight dependent dose) Receives: Drug: Ibuprofen |
| Vitamin C (Placebo) | Placebo comparator | Vitamin C was administered 1 hour prior to pin removal (weight dependent dose) Receives: Other: Vitamin C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Score (0 -10)
Pain score is measured using the Wong-Baker Scale
Measured: 10 minutes after pin removal
Secondary outcomes (1)
Pulse rate
Pulse rate is measured using a pulse oximeter (Nellcor Puritan Bennett - NPB-40)
Measured: 10 minutes after pin removal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2013 (estimated)
- Study startOct 2008
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Elbow FractureStudies of the same condition, open and under way.
- More trials run by KK Women's and Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- KK Women's and Children's Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Kevin Lim, MD, FRCS, Principal investigator, KK Women's & Children's Hospital, SINGAPORE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01944085
- Sponsor's protocol ID
- percpinremoval
- Status last verified
- Sep 2013
- First submitted
- 12 Sep 2013
- Last updated
- 17 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23255649Lim 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.
PubMed 24695927
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Pin Removal in the Outpatient Clinic - do Children Require Analgesia? A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01944085
- Acronym / sponsor ID
- percpinremoval
- Conditions
- Elbow Fracture
- Keywords
- children, supracondylar fracture, pin removal, analgesia, pain score
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- KK Women's and Children's HospitalOther government
- Study start
- Oct 2008
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 17 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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
See Brief Summary
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acetaminophen | Active comparator | Drug: AcetaminophenAcetaminophen was administered 1 hour prior to pin removal (weight dependent dose) |
| Ibuprofen | Active comparator | Drug: IbuprofenIbuprofen was administered 1 hour prior to pin removal (weight dependent dose) |
| Vitamin C (Placebo) | Placebo comparator | Other: Vitamin CVitamin C was administered 1 hour prior to pin removal (weight dependent dose) |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- age: 5-12 inclusive
- 2 or 3 percutaneous pins in either elbow
Key exclusion criteria (1 listed)
- documented or suspected allergies to acetaminophen or ibuprofen
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcetaminophenAlso: Paracetamol, TylenolSyrup | Drug | Acetaminophen |
| IbuprofenAlso: BrufenSyrup | Drug | Ibuprofen |
| Vitamin CAlso: Ascorbic AcidSyrup | Other | Vitamin C (Placebo) |
Primary outcome
Pain Score (0 -10)
Time frame: 10 minutes after pin removal
Pain score is measured using the Wong-Baker Scale
1 secondary outcome
Pulse rate
Time frame: 10 minutes after pin removal
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2013.
- Background: PubMed 23255649Tay 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.
- Derived from this study: PubMed 24695927Lim 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin Lim, MD, FRCS principal investigator
KK Women's & Children's Hospital, SINGAPORE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acetaminophen, Ibuprofen and Vitamin C in people with Elbow Fracture, run by KK Women's and Children's Hospital at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Score (0 -10) (time frame: 10 minutes after pin removal). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01944085, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2013.