Recruiting
Phase 2

Acetaminophen

Sponsor:

Swedish Medical Center

Code:

NCT01474304

Conditions

Craniotomy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Acetaminophen

Study Details

Brief summary:

Adding intraoperative IV acetaminophen, in addition to standard analgesics, will decrease opioid requirements over the first 12 hours of postoperative recovery following craniotomy. Opioids exacerbate symptoms of nausea and vomiting. Reducing postoperative opioid use hopefully will reduce incidence of nausea and vomiting in patients after craniotomy.

Conditions

Craniotomy

Study ID

NCT01474304

Start date

Nov, 2011

Status verified date

Sep, 2016

Primary completion date

Jun, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • At least 18 years of age
  • Weigh at least 50 kg (110.23 lbs)
  • Undergoing open, elective intracranial procedure for

  • tumor resection
  • aneurysm clipping
  • revascularization
  • Have an ASA (American Society of Anesthesiologists) physical status of 1, 2, 3, or 4
  • Able to provide written informed consent

Exclusion Criteria:

  • Significant medical disease, laboratory abnormality, or condition that, in the opinion of the investigator, would compromise patient welfare or would otherwise contraindicate study participation
  • Unable to communicate symptoms
  • Current daily opioid use (>40 mg morphine equivalent)
  • Tramadol use
  • Treated with MAO (monoamine oxidase inhibitors) inhibitors within 10 days of surgery
  • Treated with any amount of acetaminophen within 8 hours of anesthesia for surgery
  • Allergic or hypersensitive to acetaminophen or any contraindications per manufacturer's guidelines
  • Pregnancy
  • Impaired liver function
  • Participation in interventional clinical study within the last 30 days
  • Known or suspected history of alcohol or drug abuse
  • Surgery for resection of acoustic neuroma
  • Transphenoidal tumor resection

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

active comparator: Acetaminophen

Craniotomy patients will receive a 1000 mg dose of intravenous (IV) acetaminophen before incision and a second 1000 mg dose of IV acetaminophen 6 hours later.

no intervention: No acetaminophen

Patients will receive standard of care with no intraoperative doses of acetaminophen.

Interventions

Acetaminophen

1000 mg dose intravenous acetaminophen before craniotomy incision and a second 1000 mg dose intravenous acetaminophen 6 hours after surgery

Primary outcome measure

  • Total narcotic dose administered over the first 12 hours of postoperative recovery. [ Time Frame: 12 hours ]

Central Contacts and Locations

Central contacts

Becky Wood

206-320-7115becky.wood@swedish.org

Nathan Hansen

206-320-3542nathan.hansen@swedish.org

Locations

Swedish Medical Center Cherry Hill Campus

Recruiting

Seattle, Washington, United States, 98122

More Information

Sponsor

Swedish Medical Center

Last update posted

Sep 29, 2016

Last verified

Sep, 2016

Keywords

  • craniotomy
  • tumor resection
  • aneurysm
  • revascularization
  • opioid
  • nausea
  • vomiting
  • acetaminophen

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Swedish Medical Center on 2016-09-29.