A Phase 4 interventional study of Acetaminophen IV and Acetaminophen in Pain, sponsored by Dr. Niina Kleiber. Status unknown at 1 site in Canada. Open to participants aged 2 Years to 18 Years. Per ClinicalTrials.gov, last updated 2022-09-28.
Sponsored by Dr. Niina Kleiber · Phase 4, Interventional, and Supportive care
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.
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.
2,261 studies on the registry are indexed under Fractures, Bone; 325 are open to participants now.
This study's planned enrollment of 20 is below the median of 69 across 1,482 interventional studies indexed under Fractures, Bone.
Browse Fractures, Bone studies →This is the only study on the registry with Dr. Niina Kleiber as lead sponsor.
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Exclusion Criteria:
they will receive oral acetaminophen, placebo (saline) IV
Drug: Acetaminophen
they will receive IV acetaminophen, placebo oral
Drug: Acetaminophen IV
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.
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%.
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).
Time frame: 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
Time frame: During 24h (starting with the first dose of study drug)
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).
Time frame: During 24h (starting with the first dose of study drug)
Determination of oral bioavailability
Blood level of acetaminophen will be determined
Time frame: During 24 hours after the first dose of study drug
Plan to share: No
This study is status unknown, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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