Determine the Clinical Advantage of IV vs PO Acetaminophen

NCT03558555 | Completed Phase 4 Results DMC FDA Drug

• 3 other identifiers: GCO 16-1763IF#16-1763IF#2175834
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

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.

Conditions

Inguinal Hernia

Keywords

Acetaminophen; Tylenol; Intravenous versus oral

Outcome Measures

Primary Outcomes (3)

• 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

• Total MME Intraoperatively

  Total Morphine Milligram Equivalent (MME) use intraoperatively

  Day 1

• Total Narcotic Use in PACU.

  Total narcotic use in PACU expressed in total morphine milligram equivalents (MME)

  Day 1

Secondary Outcomes (3)

• PACU Length of Stay

  up to 24 hours after PACU arrival

• Patient Reported Total Narcotic Use Post-discharge

  average 7 days

• Patient Satisfaction.

  7 days post surgery

Study Arms (2)

Oral Acetaminophen

ACTIVE COMPARATOR

Patients who are randomized to have oral acetaminophen will take oral acetaminophen preoperatively and receive saline intraoperatively.

Drug: Oral Acetaminophen; Drug: Saline

Acetaminophen IV Soln

ACTIVE COMPARATOR

Patients randomized to IV acetaminophen will receive IV acetaminophen after induction of general anesthesia and will take placebo pills preoperatively.

Drug: Acetaminophen IV Soln; Drug: Placebo Pills

Interventions

Acetaminophen IV Soln DRUG

1000mg of IV acetaminophen

Acetaminophen IV Soln

Oral Acetaminophen DRUG

oral acetaminophen 975mg pills

Oral Acetaminophen

Placebo Pills DRUG

placebo match to acetaminophen

Acetaminophen IV Soln

Saline DRUG

Intravenous saline

Oral Acetaminophen

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yan Lai: lead

Study Sites (1)

Mount Sinai West Hospital

New York, New York, 10019, United States

Location

Related 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.

  PMID: 28742427 BACKGROUND

• 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.

  PMID: 15790675 BACKGROUND

• 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.

  PMID: 29200016 BACKGROUND

• 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.

  PMID: 31669049 RESULT

MeSH Terms

Conditions

Hernia, Inguinal

Interventions

Acetaminophen; Sodium Chloride

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Dr. Alopi Patel
• Organization: Icahn School of Medicine at Mount Sinai

Alopi.patel@mountsinai.org

(212) 523-6357

Study Officials

• Yan Lai, MD, MPH

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Anesthesiology, Perioperative & Pain Medicine

Model Details: Participants presenting for inguinal hernia surgery are assigned to either the oral or intravenous acetaminophen group

Study Record Dates

• First Submitted: June 4, 2018
• First Posted: June 15, 2018
• Study Start: December 8, 2017
• Primary Completion: December 30, 2018
• Study Completion: December 30, 2018
• Last Updated: February 10, 2020
• Results First Posted: February 10, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)