Clinical trial NCT03558555: Determine the Clinical Advantage of IV vs PO Acetaminophen
Official title: Comparative Efficacy of Intravenous Acetaminophen vs. Oral Acetaminophen in Ambulatory Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Inguinal Hernia
Keywords: Acetaminophen
Tylenol
Intravenous versus oral
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2018-06-15
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants presenting for inguinal hernia surgery are assigned to either the oral or intravenous acetaminophen group
Primary purpose: TREATMENT

Brief summary: There is limited research on the clinical outcome differences between intravenous (IV) acetaminophen versus oral (PO) acetaminophen. With the costs of intravenous acetaminophen sometimes being almost 100 times the cost of PO acetaminophen, it is not only important fiscally but also clinically to differentiate the benefits of IV vs PO acetaminophen. The proposed research study is to determine the clinical advantages of IV vs PO acetaminophen during the post-operative recovery time for ambulatory surgery patients by analyzing differences in time to first opioid delivery, pain scores, and patient satisfaction.

Detailed description: In previous literature it has been shown that compared to placebo, IV acetaminophen can improve postoperative pain scores and reduce opioid requirements. In addition, IV acetaminophen has several pharmacokinetic properties that may be beneficial when compared to acetaminophen. IV acetaminophen has been shown to achieve a more rapid and higher maximum plasma concentration as well as higher cerebrospinal fluid concentrations. Comparative effectiveness trials of IV vs PO administration have not conclusively demonstrated improved clinical outcomes despite the proposed pharmacokinetic benefits. More research needs to be conducted to determine possible clinical advantages.

Eligibility criteria: Inclusion Criteria:

* ASA scores I-III
* Ambulatory surgery patients
* Ages 18-75
* Surgeries requiring general anesthesia for hernia surgery

Exclusion Criteria:

* Patients with contraindications to acetaminophen (history of end organ liver dysfunction)
* Known allergy to acetaminophen
* Emergency surgery
* Patients who were not fasted
* Patients who cannot tolerate PO
* Surgery anticipated to last longer than 3 hours or requiring re-dose of acetaminophen
* Pregnancy
* Weight less than 50kg
* Chronic daily narcotic use
* Patients who's anesthetic plan requires regional anesthesia
* Patient refusal to participate or do not have capacity to provide consent.

Primary outcomes:
measure: PACU Visual Analogue Pain Scores
timeFrame: baseline, 1 hour, and Day 1 discharge
measure: Total MME Intraoperatively
timeFrame: Day 1
measure: Total Narcotic Use in PACU.
timeFrame: Day 1
Secondary outcomes:
measure: PACU Length of Stay
timeFrame: up to 24 hours after PACU arrival
measure: Patient Reported Total Narcotic Use Post-discharge
timeFrame: average 7 days
measure: Patient Satisfaction.
timeFrame: 7 days post surgery
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai West Hospital
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Yan Lai, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Helander EM, Webb MP, Bias M, Whang EE, Kaye AD, Urman RD. A Comparison of Multimodal Analgesic Approaches in Institutional Enhanced Recovery After Surgery Protocols for Colorectal Surgery: Pharmacological Agents. J Laparoendosc Adv Surg Tech A. 2017 Sep;27(9):903-908. doi: 10.1089/lap.2017.0338. Epub 2017 Jul 25.
citation: Moller PL, Sindet-Pedersen S, Petersen CT, Juhl GI, Dillenschneider A, Skoglund LA. Onset of acetaminophen analgesia: comparison of oral and intravenous routes after third molar surgery. Br J Anaesth. 2005 May;94(5):642-8. doi: 10.1093/bja/aei109. Epub 2005 Mar 24.
citation: Olbrecht VA, Ding L, Spruance K, Hossain M, Sadhasivam S, Chidambaran V. Intravenous Acetaminophen Reduces Length of Stay Via Mediation of Postoperative Opioid Consumption After Posterior Spinal Fusion in a Pediatric Cohort. Clin J Pain. 2018 Jul;34(7):593-599. doi: 10.1097/AJP.0000000000000576.
citation: Patel A, Pai B H P, Diskina D, Reardon B, Lai YH. Comparison of clinical outcomes of acetaminophen IV vs PO in the peri-operative setting for laparoscopic inguinal hernia repair surgeries: A triple-blinded, randomized controlled trial. J Clin Anesth. 2020 May;61:109628. doi: 10.1016/j.jclinane.2019.109628. Epub 2019 Oct 25.