University of California Davis Children's Hospital
Sacramento, California, 95817, United States
NCT Number: NCT02994940
Acetaminophen is frequently used as an adjunct for pain management in pediatric surgical patients. The drug is available in an over the counter, inexpensive oral form as well as a considerably more expensive intravenous form. This study will compare opioid requirements and acetaminophen plasma levels post operatively for two dosing regimens to compare oral versus intravenous routes given pre operatively.
Looking for future studies?
Notify Me3 year–17 year
All sexes
Interventional
Phase 4
Sacramento, California, 95817, United States
The primary purpose of this study is to compare opioid utilization in post-operative patients undergoing tonsillectomy and adenoidectomy, between IV and PO acetaminophen. Secondarily, it will provide information regarding possible cost savings, pharmacokinetics and safety between these two regimens.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
already included in arm/group descriptions
Other names: OFIRMEV
Time frame: Within 24hrs
Total dose of opioid, in morphine equivalents, that the patient receives for breakthrough pain in the 24 hour period following surgery.
Time frame: 24 hrs period following surgery
A secondary endpoint is the proportion of patients with pain scores in the severe pain range (7 or higher) on numeric pain rating scale of 0 to 10; higher score more severe.
Time frame: at the end of surgery, about 1 hour after IV Dose
mg/L acetaminophen in the plasma at the end of surgery
Time frame: Outcome will be measured 3hrs post first IV Dose
mg/L acetaminophen in the plasma 3 hours after IV study drug administration
University of California, Davis
Other
Acronym: MODIV-APAP
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06763276
Adenoidectomy, Tonsillectomy
Izmir, Buca, Turkey (Türkiye)
View Trial DetailsNCT06122948
Adenoidectomy, Chemically-Induced Disorders
Cairo, Egypt
View Trial DetailsNCT00581139
Adenoidectomy, Care, Postoperative
New Haven, Connecticut, United States
View Trial DetailsNCT00836264
Adenoidectomy, Pharmacokinetics
Philadelphia, Pennsylvania, United States
View Trial Details