PainPhase 4NCT05557344
Oral vs IV Acetaminophen for Long-bone Fracture in Children
A Phase 4 study testing Acetaminophen IV and Acetaminophen in people with Pain, run by Dr. Niina Kleiber at 1 site in Canada.
Trial summary
Intravenous (IV) acetaminophen entered the Canadian market recently and children with acute pain following a trauma are ideal candidates for the IV formulation as it may improve analgesia and consequently decrease the amount of opioids needed to achieve pain control. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Pain
- What is being tested?
- Acetaminophen IV and Acetaminophen
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 21 Apr 2021to 1 Mar 2024
- Phase
- Phase 4
- 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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Likely to undergo surgery for a long-bone fracture
- Aged between 2-18 years (IV acetaminophen is approved for children ≥2 years)
- IV line per standard of care
Who cannot join
- Contraindication to oral drug administration
- Patients unable to take oral solution
- Known hypersensitivity or allergy to acetaminophen or any of the excipients in the IV or oral formulation
- Use of any medication known to interact with acetaminophen including, but not restricted to phenytoin and carbamazepine (1)
- Pregnancy
- Known Hepatic insufficiency or hepatic disease
Show all 10Show fewer
- Known or diagnosed severe renal failure
- Multiple trauma (more than two long bone fractures)
- Hemodynamic or respiratory compromise
- Altered level of consciousness (Glasgow coma scale <15)
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
CHU Sainte-Justine
Montreal, Quebec
Niina kleiber, MD, 514 3454931, niina.kleiber.med@ssss.gouv.qc.ca
About this study
Official title: Oral Versus Intravenous Acetaminophen for the Treatment of Pain Secondary to Long Bone Fracture Requiring Surgery in Children
Intravenous (IV) acetaminophen entered the Canadian market recently and children with acute pain following a trauma are ideal candidates for the IV formulation as it may improve analgesia and consequently decrease the amount of opioids needed to achieve pain control. Due to the limited data on bioavailability, adverse effect profile and efficacy of IV versus oral acetaminophen, it is of paramount importance to generate evidence-based data to guide clinicians with a rational choice of route of administration of acetaminophen.
Therefore, we propose a pilot study to inform a future large randomized controlled trial (RCT) to compare pharmacokinetics, feasibility, preliminary effects and side effects profile of oral versus IV acetaminophen in children admitted for surgical fixation of a long-bone fracture.
Read the detailed description
Patients admitted for a long-bone fracture needing surgical fixation are generally initially treated with intranasal and/or IV opioids in association to oral acetaminophen and ibuprofen. Following surgery they are treated with a combination of morphine and acetaminophen. To address the issue of opioid epidemics, the Pediatric Orthopaedic Society of North America recommends reduction of their prescription as much as possible by promoting, among others, use of multimodal analgesia after surgery. The current proposal aims to improve post-operative pain control in children following a surgical fixation of a long-bone fracture and decrease the use of opioids through better co-analgesia. As such, this study aims to assess the pharmacokinetics (PK) and the efficacy of oral versus IV formulations of acetaminophen after surgery for long bone fractures in children.
- Conditions
- Pain
- Being tested
- Acetaminophen IV, Acetaminophen
- Keywords
- pain, analgesics, pediatrics, acetaminophen, orthopedics, pharmacokinetics
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acetaminophen IVDrug
An IV infusion of 15mg/kg of acetaminophen (PrACETAMINOPHEN INJECTION, AVIR Pharma Inc.) (maximum single dose:1g) will be administered regularly every 6h as a 15-minute intravenous infusion. At the same time, an oral placebo with similar appearance as the corresponding acetaminophen oral solution will be administered.
AcetaminophenDrug
A liquid oral acetaminophen suspension will be administered regularly every 6h at a dose of 15mg/kg (maximum single dose: 1g). An IV infusion of NaCl 0.9% corresponding to the volume of IV acetaminophen will be administered as a 15-minute intravenous infusion at the same time as the oral dose. PrACETAMINOPHEN INJECTION ® is a clear and colorless liquid undistinguishable from NaCl 0.9%.
| Study group | Role | What they receive |
|---|---|---|
| Oral acetaminophen arm | Active comparator | they will receive oral acetaminophen, placebo (saline) IV Receives: Drug: Acetaminophen |
| IV acetaminophen arm | Active comparator | they will receive IV acetaminophen, placebo oral Receives: Drug: Acetaminophen IV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain scores
Pain scores within the first 24 hours following initiation of study drug, using the scales Face, Legs, Activity, Cry, Consolability (FLACC, 0-2 per item for a total of 10, 10 being the worst pain) and verbal numerical rating (VNR, 0-10, 10 being the worst pain).
Measured: During 24h (starting with the first dose of study drug)
Difference in quantity of rescue opioids
Quantity of rescue opioids (morphine equivalent in mg/kg) within the first 24 hours following initiation of study drug
Measured: During 24h (starting with the first dose of study drug)
Secondary outcomes (2)
Adverse events
Any other adverse effect whether or not attributed to the study drug will be carefully recorded. Opioid-related adverse effects will be recorded (pruritus, time to first bowel movement, nausea (self-reported), vomiting, days of bladder catheterization, oxygen supplementation, episodes of respiratory depression (< 10/min in children older than 5 years), use of diphenhydramine, naloxone, antiemetics, laxatives).
Measured: During 24h (starting with the first dose of study drug)
Determination of oral bioavailability
Blood level of acetaminophen will be determined
Measured: During 24 hours after the first dose of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2022
- Study start21 Apr 2021
- Primary completion1 Sep 2023 (estimated)
- Study completion1 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Niina Kleiber
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Niina Kleiber, St. Justine's Hospital
- Investigators
- Niina Kleiber, MD PhD, Principal investigator, St. Justine's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05557344
- Sponsor's protocol ID
- Acetaminophen IV vs PO
- Status last verified
- Sep 2022
- First submitted
- 24 Aug 2022
- Last updated
- 28 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ulrich M, Chamberland M, Bertoldi C, Garcia-Bournissen F, Kleiber N. Newly approved IV acetaminophen in Canada: Switching from oral to IV acetaminophen. Is IV worth the price difference? A systematic review. Paediatr Child Health. 2021 Mar 13;26(6):337-343. doi: 10.1093/pch/pxaa137. eCollection 2021 Oct.
PubMed 34676011
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Versus Intravenous Acetaminophen for the Treatment of Pain Secondary to Long Bone Fracture Requiring Surgery in Children
- ClinicalTrials.gov ID
- NCT05557344
- Acronym / sponsor ID
- Acetaminophen IV vs PO
- Conditions
- Pain
- Keywords
- pain, analgesics, pediatrics, acetaminophen, orthopedics, pharmacokinetics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Dr. Niina KleiberUniversity, hospital or other
- Study start
- 21 Apr 2021 (actual)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 28 Sep 2022 (actual)
- 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.
Intravenous (IV) acetaminophen entered the Canadian market recently and children with acute pain following a trauma are ideal candidates for the IV formulation as it may improve analgesia and consequently decrease the amount of opioids needed to achieve pain control. Due to the limited data on bioavailability, adverse effect profile and efficacy of IV versus oral acetaminophen, it is of paramount importance to generate evidence-based data to guide clinicians with a rational choice of route of administration of acetaminophen.
Therefore, we propose a pilot study to inform a future large randomized controlled trial (RCT) to compare pharmacokinetics, feasibility, preliminary effects and side effects profile of oral versus IV acetaminophen in children admitted for surgical fixation of a long-bone fracture.
Detailed description
Patients admitted for a long-bone fracture needing surgical fixation are generally initially treated with intranasal and/or IV opioids in association to oral acetaminophen and ibuprofen. Following surgery they are treated with a combination of morphine and acetaminophen. To address the issue of opioid epidemics, the Pediatric Orthopaedic Society of North America recommends reduction of their prescription as much as possible by promoting, among others, use of multimodal analgesia after surgery. The current proposal aims to improve post-operative pain control in children following a surgical fixation of a long-bone fracture and decrease the use of opioids through better co-analgesia. As such, this study aims to assess the pharmacokinetics (PK) and the efficacy of oral versus IV formulations of acetaminophen after surgery for long bone fractures in children.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral acetaminophen arm | Active comparator | Drug: Acetaminophenthey will receive oral acetaminophen, placebo (saline) IV |
| IV acetaminophen arm | Active comparator | Drug: Acetaminophen IVthey will receive IV acetaminophen, placebo oral |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Likely to undergo surgery for a long-bone fracture
- Aged between 2-18 years (IV acetaminophen is approved for children ≥2 years)
- IV line per standard of care
Key exclusion criteria (10 listed)
- Contraindication to oral drug administration
- Patients unable to take oral solution
- Known hypersensitivity or allergy to acetaminophen or any of the excipients in the IV or oral formulation
- Use of any medication known to interact with acetaminophen including, but not restricted to phenytoin and carbamazepine (1)
- Pregnancy
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 |
|---|---|---|
| Acetaminophen IVAn IV infusion of 15mg/kg of acetaminophen (PrACETAMINOPHEN INJECTION, AVIR Pharma Inc.) (maximum single dose:1g) will be administered regularly every 6h as a 15-minute intravenous infusion. At the same time, an oral placebo with similar appearance as the corresponding acetaminophen oral solution will be administered. | Drug | IV acetaminophen arm |
| AcetaminophenA liquid oral acetaminophen suspension will be administered regularly every 6h at a dose of 15mg/kg (maximum single dose: 1g). An IV infusion of NaCl 0.9% corresponding to the volume of IV acetaminophen will be administered as a 15-minute intravenous infusion at the same time as the oral dose. PrACETAMINOPHEN INJECTION ® is a clear and colorless liquid undistinguishable from NaCl 0.9%. | Drug | Oral acetaminophen arm |
Primary outcome
Change in pain scores
Time frame: During 24h (starting with the first dose of study drug)
Pain scores within the first 24 hours following initiation of study drug, using the scales Face, Legs, Activity, Cry, Consolability (FLACC, 0-2 per item for a total of 10, 10 being the worst pain) and verbal numerical rating (VNR, 0-10, 10 being the worst pain).
Difference in quantity of rescue opioids
Time frame: During 24h (starting with the first dose of study drug)
Quantity of rescue opioids (morphine equivalent in mg/kg) within the first 24 hours following initiation of study drug
2 secondary outcomes
Adverse events
Time frame: During 24h (starting with the first dose of study drug)
Determination of oral bioavailability
Time frame: During 24 hours after the first dose of study drug
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2022.
- Background: PubMed 34676011Ulrich M, Chamberland M, Bertoldi C, Garcia-Bournissen F, Kleiber N. Newly approved IV acetaminophen in Canada: Switching from oral to IV acetaminophen. Is IV worth the price difference? A systematic review. Paediatr Child Health. 2021 Mar 13;26(6):337-343. doi: 10.1093/pch/pxaa137. eCollection 2021 Oct.
- Individual participant dataSharing planned: No
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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.
Niina Kleiber, MD PhD principal investigator
St. Justine's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Acetaminophen IV and Acetaminophen in people with Pain, run by Dr. Niina Kleiber at 1 site in Canada.
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 3 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 28 Sep 2022. 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 Canada. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Niina Kleiber, MD ((514) 3454931, niina.kleiber.med@ssss.gouv.qc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain scores (time frame: During 24h (starting with the first dose of study drug)). The study lists 2 primary outcomes in all. 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 NCT05557344, which also lists 1 linked publication.
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 28 Sep 2022.