Intravenous Acetaminophen in Craniotomy

NCT01598701 | Completed Phase 4 Results FDA Drug

• 1 other identifier: HSC-MS-12-0055
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the use of intravenous Acetaminophen (OFIRMEV) as an effective adjunct therapeutic agent in patients undergoing craniotomy.

Conditions

Postoperative Pain

Keywords

Acetaminophen; Intravenous Acetaminophen; Opioid Requirement; Pain; Post-Operative Pain; Craniotomy; Post-Craniotomy Pain

Outcome Measures

Primary Outcomes (1)

• Post-Operative Opioid Requirement

  Opioid Consumption will be monitored in the first 24 post-operative hours. All non-opioid analgesics are disallowed. Total opioid consumption was calculated based on morphine equivalents (MEs), where 1 mg of IV morphine was equivalent to 1 ME, and 1 mg IV hydromorphone was calculated as 7 MEs.

  24 hours post-operatively

Secondary Outcomes (4)

• Post-Operative Pain

  24 Hours Post-Operatively

• Post-Operative Side Effects

  24 Hours Post-Operatively

• Time to Extubation at Emergence From Anesthesia

  Time from of discontinuation of anesthetic to time of extubation, an average of 7 minutes

• Time for Patient to Meet Post-anesthesia Care Unit (PACU) Discharge Criteria

  From time of entry to PACU to time to meet PACU discharge criteria, an average of 12 minutes

Study Arms (2)

Intravenous Acetaminophen

EXPERIMENTAL

Patients will be receive doses of 1000 mg/100 mL of IV Acetaminophen (OFIRMEV). The drug will be infused over 15 minutes.

Drug: Acetaminophen

Placebo

PLACEBO COMPARATOR

Patients will be given 100 mL normal saline placebos at scheduled time intervals in place of IV acetaminophen.

Drug: Placebo

Interventions

Acetaminophen DRUG

Intravenous Acetaminophen, 1000 mg/100mL, Every 6 hours, Infused over 15 minutes.

Also known as: OFIRMEV

Intravenous Acetaminophen

Placebo DRUG

100 mL 0.9% Sodium Chloride

Also known as: 0.9% Sodium Chloride

Placebo

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults
• Undergoing Craniotomy for Supratentorial Tumor Resection
• Weight between 50 and 120 kilograms
• ASA Physical Status I-III
• Be able to communicate verbally
• Be able to use Visual Analog Score

You may not qualify if:

• Allergies to acetaminophen, morphine or any of the anesthetic agents required by the protocol.
• Use of opioids, tramadol, benzodiazepines, or gabapentin on a daily basis for \> 7 days prior to the day of surgery.
• Use of acetaminophen, NSAIDs, or any other analgesic medication in the 12 hours immediately prior to study enrollment.
• Hepatic insufficiency (elevated transaminases \> 1.5 times the upper limit of normal) or renal insufficiency (plasma creatinine \> 2mg/dl).
• Known or suspected history of alcohol or illicit drug abuse.
• Pregnant or breast-feeding.
• Surgical plan for infratentorial (suboccipital) craniotomy.
• Plan for neurophysiologic monitoring that precludes the use of neuromuscular blockade.
• Inability to communicate due to a language barrier, impaired consciousness, cognitive defect or intellectual disability.
• Uncontrolled Hypertension

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• Mallinckrodt: collaborator

Study Sites (1)

Memorial Hermann Hospital - Texas Medical Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Artime CA, Aijazi H, Zhang H, Syed T, Cai C, Gumbert SD, Ferrario L, Normand KC, Williams GW, Hagberg CA. Scheduled Intravenous Acetaminophen Improves Patient Satisfaction With Postcraniotomy Pain Management: A Prospective, Randomized, Placebo-controlled, Double-blind Study. J Neurosurg Anesthesiol. 2018 Jul;30(3):231-236. doi: 10.1097/ANA.0000000000000461.

  PMID: 29117012 RESULT

MeSH Terms

Conditions

Pain, Postoperative; Pain

Interventions

Acetaminophen; Sodium Chloride

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Limitations and Caveats

Not powered to detect differences in pain score. Patients were not given a patient-controlled analgesia device; rather, administration of morphine was dependent on nurse administration.

Results Point of Contact

• Title: Carlos Artime, MD
• Organization: University of Texas Health Science Center at Houston

Carlos.Artime@uth.tmc.edu

713-500-6200

Study Officials

• Carlos A. Artime, MD

  University of Texas Health Sciences Center at Houston

  PRINCIPAL INVESTIGATOR

• Sam D. Gumbert, MD

  University of Texas Health Sciences Center at Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor - Anesthesiology

Study Record Dates

• First Submitted: May 9, 2012
• First Posted: May 15, 2012
• Study Start: May 2, 2012
• Primary Completion: March 30, 2016
• Study Completion: March 30, 2016
• Last Updated: June 19, 2018
• Results First Posted: June 19, 2018

Record last verified: 2018-05

Locations

US (1)