Intravenous Acetaminophen to Reduce Post-operative Opioid Consumption

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre hospitalier de l'Université de Montréal (CHUM)

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

140 Participants
are divided into 2 treatment groups
Group A: Pre-intervention arm (standard protocol containing PO or IR Acetaminophen)No intervention 0 interventions
Group B: Post-intervention arm (modified protocol containing IV Acetaminophen)Active comparator 1 intervention

Trial outcomes

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).

Time frame
72 hours

Secondary outcomes

1

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

To determine whether the systematic use of IV acetaminophen reduces the average opioid consumption in MME over the first 24 and 48 postoperative hours in the post-intervention period compared to the pre-intervention period.

Time frame
48 hours

Other outcomes

1

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

Compare the variation in resting pain levels during the periods of 0 to 24 hours, 24 to 48 hours, 0 to 48 hours, 48 to 72 hours, and 0 to 72 hours between the pre-intervention and post-intervention periods. This simple scale asks patients to rate their pain on a scale from zero (no pain) to ten (maximum pain).

Time frame
72 hours
2

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

Compare the average pain level during mobilization (upon standing) on postoperative days 0, 1, and 2 between the pre-intervention and post-intervention periods. This simple scale asks patients to rate their pain on a scale from zero (no pain) to ten (maximum pain)

Time frame
72 hours
3

Length of hospital stay

Compare the length of hospital stay in days from the end of surgery until hospital discharge between the pre-intervention and post-intervention periods.

Time frame
From date of the abdominal surgery until the date of hospital discharge, assessed up to 6 months
4

Nausea and constipation (antiemetic doses, laxative use)

Compare the frequency of nausea and constipation between the pre-intervention and post-intervention periods

Time frame
72 hours

Sponsors and contacts

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