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Could IV tylenol replace opioids after brain surgery?

NCT ID NCT01739699

Symptom relief Sponsor: Endeavor Health Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether giving intravenous acetaminophen (Tylenol) during and after brain surgery could reduce the need for opioid painkillers. 140 adults having open brain surgery were randomly assigned to receive either IV Tylenol or a placebo. The main goal was to see if more patients in the Tylenol group could avoid opioids entirely in the first 24 hours after surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
acetaminophen (Tylenol)
What this could lead to
If it works, this could offer a safer way to manage pain after brain surgery, reducing the need for strong opioids.
What could go wrong
This is a small, completed Phase 4 trial. Results may not apply to all patients or surgeries, and IV acetaminophen may not be effective for everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

140 people

The number who actually took part.

Start date

Jan 2012

Finished

Jan 2017

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 90 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Subject are able to provide informed consent prior to participation in the study * Subjects must be scheduled to undergo elective open craniotomy procedure of \> 2 hour duration * Subjects must be \>18 years old but less than 90 years old * Subjects must have an American Society of Anesthesiologists (ASA) class I-IV * Subjects must have the ability to communicate meaningfully with the investigator staff and read/understand the study procedures and the use of pain scales Exclusion Criteria: * Subjects used opioids or tramadol daily for \>7 days before study medication administration * Subjects had been treated with any of the following within 14 days of surgery: chaparral, comfrey, germander, jin bu huan, kava, pennyroyal, skullcap, St. John's wort, or valerian * Subjects who have a chronic pain condition, significant medical disease or laboratory abnormality that in the investigator's judgment could compromise the subject's welfare * Subjects with known hypersensitivity to opioids, acetaminophen or the inactive ingredients * Subjects with known or suspected history of alcohol or drug abuse or dependence in the previous 2 years prior to the proposed surgery

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Brain surgery Craniotomy

Contacts and locations

Locations

  • NorthShore University HealthSystem

    Evanston, Illinois, 60201, United States

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