Intravenous Acetaminophen to Reduce Post-operative Opioid Consumption

NCT06923540 | Not Yet Recruiting Phase 4

• 1 other identifier: 2025-12623
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

Acetaminophen (Tylenol) is a commonly used medication after surgery to control pain. Tablets for oral use and suppositories for rectal use are the most frequently employed forms of acetaminophen after surgery. Intravenous (IV) acetaminophen is widely used in several countries but is not a standard medication for the adult population in Canada. It is mainly considered when it is impossible to take medication in tablet or suppository form. Opioids (Morphine, Hydromorphone, Oxycodone, etc.) are another class of medications commonly used after surgery for pain management. While they are generally very effective and stronger than acetaminophen or other pain relievers (e.g., ibuprofen/Advil), reducing their use is preferable, as they can cause various side effects such as nausea, dizziness, and dependence. IV acetaminophen may help control pain while also reducing opioid consumption. However, there are few high-quality scientific studies proving the benefits of IV acetaminophen compared to other forms, such as tablets or suppositories. Acetaminophen has been available in Canada for many years and has already been recommended for use in Quebec by the Institut national d'excellence en santé et services sociaux (INESSS) under certain conditions. This study aims to validate its benefits with clear data.

Conditions

Post Operative Analgesia; Opioid Consumption, Postoperative; Acetaminophen; Abdominal Surgeries; Post Operative Bowel Dysfunction; Post Operative Nausea and Vomiting; Post Operative Pain Control; Mobility; Epidural Analgesia; Length of Stay; Pain Management

Keywords

IV acetaminophen; intravenous acetaminophen; acetaminophen; post operative analgesia; nil per os; npo; post operative pain; opioid consumption; abdominal surgery; hepato-biliary surgery; digestive surgery; pancreatic surgery; gynecologic surgery; post operative nausea and vomiting; post operative mobility; hospitalization length of stay; co-analgesia

Outcome Measures

Primary Outcomes (1)

• Opioid consumption in oral morphine milligram equivalents (MME)

  To determine whether the systematic use of IV acetaminophen in adult NPO patients in the postoperative context of abdominal surgery (post-intervention) reduces the average opioid consumption in oral morphine milligram equivalents (MME) over 72 hours compared to the standard protocol, which includes PO or IR acetaminophen (pre-intervention).

  72 hours

Secondary Outcomes (1)

• Opioid consumption (converted to MME) at 24 and 48 hours postoperatively

  48 hours

Other Outcomes (5)

• Pain level at rest (on a scale from 0 to 10) during the first 72 hours.

  72 hours

• Pain level during mobilization (on a scale from 0 to 10) during the first 72 hours

  72 hours

• Length of hospital stay

  From date of the abdominal surgery until the date of hospital discharge, assessed up to 6 months

Study Arms (2)

Pre-intervention arm (standard protocol containing PO or IR Acetaminophen)

NO INTERVENTION

This arm will receive the protocol currently used at the CHUM surgical units for post operative pain management, which includes PO or IR acetaminophen.

Post-intervention arm (modified protocol containing IV Acetaminophen)

ACTIVE COMPARATOR

This arm will receive a modified protocol version of the one used at the CHUM surgical units for post operative pain management, which includes IV acetaminophen.

Drug: IV Acetaminophen

Interventions

IV Acetaminophen DRUG

This intervention will be administered to patients undergoing abdominal surgery who are nil per os (NPO) directly after surgery. This patient group has not been properly studied in other clinical studies using IV Acetaminophen. The study aim is to determine if patients who have an altered enteral route may benefit from IV Acetaminophen.

Post-intervention arm (modified protocol containing IV Acetaminophen)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older.
• Underwent abdominal surgery
• Underwent elective surgery.
• Hospitalized in the digestive surgery, hepatobiliary and pancreatic surgery, or gynecology and gynecologic oncology units at CHUM.
• Declared NPO immediately post-surgery, meaning they cannot take oral medications.

You may not qualify if:

• Hypersensitivity to acetaminophen or an excipient in the administered formulations
• Hepatic insufficiency with a Child-Turcotte-Pugh score of B or C.
• Weight \< 50 kg (patients requiring a lower acetaminophen dose).
• Active pregnancy or breastfeeding.
• Opioid use disorder (OUD) under active treatment
• Non-opioid-naïve patients: those who received a long-acting opioid within seven days preceding surgery. This criterion will be verified through patient interviews and cross-checked with medical records.
• Use of illicit recreational substances.
• Prior participation in this study.
• Ectopic patients: physically located in a unit other than digestive surgery (11 South), hepatobiliary and pancreatic surgery (14 South), or gynecology and gynecologic oncology (12 South).

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead

Study Sites (1)

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, H2X 0A9, Canada

Location

MeSH Terms

Conditions

Vomiting; Agnosia; Pain, Postoperative

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pain

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Franck Vandenbroucke-Menu, MD

  Centre hospitalier de l'Université de Montréal (CHUM)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Suhail Sami Jouni, BSc, PharmD, MSc

CONTACT

514-890-8000; suhail.sami.jouni.chum@ssss.gouv.qc.ca

Thierry Nader, PharmD, MSc candidate

CONTACT

514-890-8000; thierry.nader.chum@ssss.gouv.qc.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study design is quasi-experimental in pre post fashion. * Part 1: participants will receive the standard post-operative protocol, which includes Acetaminophen PO or IR. * Part 2 : participants will receive the modified post-operative protocol, which includes IV Acetaminophen.

Study Record Dates

• First Submitted: March 13, 2025
• First Posted: April 11, 2025
• Study Start: April 28, 2025
• Primary Completion: August 15, 2025
• Study Completion: August 15, 2025
• Last Updated: April 11, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)