NCT01474304

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

November 9, 2011

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 18, 2011

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Last Updated

September 29, 2016

Status Verified

September 1, 2016

Enrollment Period

5.6 years

First QC Date

November 9, 2011

Last Update Submit

September 27, 2016

Conditions

Craniotomy

Keywords

craniotomytumor resectionaneurysmrevascularizationopioidnauseavomitingacetaminophen

Outcome Measures

Primary Outcomes (1)

  • Total narcotic dose administered over the first 12 hours of postoperative recovery.

    Intensive care nurses will ask subject about pain and nausea every 15 minutes for the first two hours immediately after surgery and then every hour afterward for up to 12 hours. Nurses will record subject response and opioid doses given.

    12 hours

Secondary Outcomes (4)

  • Incidence of nausea during postoperative recovery

    12 hours

  • Incidence of vomiting during postoperative recovery

    12 hours

  • Severity of nausea during postoperative recovery

    12 hours

  • Severity of vomiting during postoperative recovery

    12 hours

Study Arms (2)

Acetaminophen

ACTIVE COMPARATOR

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.

Drug: Acetaminophen

No acetaminophen

NO INTERVENTION

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

Interventions

AcetaminophenDRUG

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

Acetaminophen

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Swedish Medical Center Cherry Hill Campus

Seattle, Washington, 98122, United States

RECRUITING

MeSH Terms

Conditions

AneurysmNauseaVomiting

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Arthur Lam, MD, FRCPC

    Swedish Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Becky Wood

CONTACT

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

Nathan Hansen

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2011

First Posted

November 18, 2011

Study Start

November 1, 2011

Primary Completion

June 1, 2017

Last Updated

September 29, 2016

Record last verified: 2016-09

Locations

US(1)