Determine the Clinical Advantage of IV vs PO Acetaminophen

Inguinal Hernia Clinical Trial

Official title:

Comparative Efficacy of Intravenous Acetaminophen vs. Oral Acetaminophen in Ambulatory Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03558555
• Other study ID #: GCO 16-1763
• Secondary ID: IF#16-1763IF#217
• Status: Completed
• Phase: Phase 4
• Start date: December 8, 2017
• Est. completion date: December 30, 2018

Study information

• Verified date: January 2020
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: December 30, 2018
• Est. primary completion date: December 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hernia, Inguinal
• Inguinal Hernia

Intervention

Drug:
• Acetaminophen IV Soln
1000mg of IV acetaminophen
• Oral Acetaminophen
oral acetaminophen 975mg pills
• Placebo Pills
placebo match to acetaminophen
• Saline
Intravenous saline

Locations

Country	Name	City	State
United States	Mount Sinai West Hospital	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Yan Lai

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. Epub 2005 Mar 24. — View 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. — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PACU Visual Analogue Pain Scores	Post-Anesthesia Care Unity (PACU) pain scores at baseline, 1 hour, and on discharge from PACU. Pain score by visual analogue score, total scale from 0 to 10 with 10 being the worse pain.	baseline, 1 hour, and Day 1 discharge
Primary	Total MME Intraoperatively	Total Morphine Milligram Equivalent (MME) use intraoperatively	Day 1
Primary	Total Narcotic Use in PACU.	Total narcotic use in PACU expressed in total morphine milligram equivalents (MME)	Day 1
Secondary	PACU Length of Stay	Time in PACU	up to 24 hours after PACU arrival
Secondary	Patient Reported Total Narcotic Use Post-discharge	home opiod use	average 7 days
Secondary	Patient Satisfaction.	Patient satisfaction total scale from 1 to 10, with higher score indicating more satisfaction	7 days post surgery