Modified Pre-operative Oral Doses Acetaminophen Versus Intravenous Acetaminophen (MODIV-APAP)
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|ClinicalTrials.gov Identifier: NCT02994940|
Recruitment Status : Completed
First Posted : December 16, 2016
Last Update Posted : October 9, 2019
|Condition or disease||Intervention/treatment||Phase|
|Tonsillectomy Adenoidectomy||Drug: Acetaminophen||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Modified Pre-operative Oral Doses Acetaminophen Versus Intravenous Acetaminophen|
|Actual Study Start Date :||November 11, 2016|
|Actual Primary Completion Date :||July 2019|
|Actual Study Completion Date :||August 2019|
Experimental: Oral Acetaminophen
Group 1 will receive oral acetaminophen 30mg/kg 30-60 minutes prior to scheduled surgery time . Group 1 patients will receive placebo IV infusion just prior to surgery incision.
Experimental: Intravenous Acetaminophen
Group 2 will receive placebo oral medication at approximately 30-60 minutes prior to scheduled surgery. Group 2 patients will receive IV acetaminophen 15 mg/kg just prior to surgery incision.
- Total Dose of Opioid [ Time Frame: After 24hrs ]Total dose of opioid, in morphine equivalents, that the patient receives for breakthrough pain in the 24 hour period following surgery.
- Pain Score Proportions [ Time Frame: 24hrs period following surgery ]A secondary endpoint is the proportion of pain scores in the mild, moderate or severe pain ranges.
- Plasma Acetaminophen level 1 [ Time Frame: 1 hour after IV Dose ]mg/L acetaminophen in the plasma
- Plasma Acetaminophen level 2 [ Time Frame: Outcome will be measured 3hrs post first IV Dose ]mg/L acetaminophen in the plasma
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): NCT02994940
|United States, California|
|University of California Davis Children's Hospital|
|Sacramento, California, United States, 95817|
|Principal Investigator:||Cathy Lammers, MD||UC Davis Children's Hospital|