Intravenous Acetaminophen in Craniotomy
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|ClinicalTrials.gov Identifier: NCT01598701|
Recruitment Status : Completed
First Posted : May 15, 2012
Results First Posted : June 19, 2018
Last Update Posted : June 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|Postoperative Pain||Drug: Acetaminophen Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||The Opioid-Sparing and Analgesic Effects of IV Acetaminophen in Craniotomy: A Prospective, Randomized, Placebo-Controlled, Double-Blind Study|
|Actual Study Start Date :||May 2, 2012|
|Actual Primary Completion Date :||March 30, 2016|
|Actual Study Completion Date :||March 30, 2016|
Experimental: Intravenous Acetaminophen
Patients will be receive doses of 1000 mg/100 mL of IV Acetaminophen (OFIRMEV). The drug will be infused over 15 minutes.
Intravenous Acetaminophen, 1000 mg/100mL, Every 6 hours, Infused over 15 minutes.
Other Name: OFIRMEV
Placebo Comparator: Placebo
Patients will be given 100 mL normal saline placebos at scheduled time intervals in place of IV acetaminophen.
100 mL 0.9% Sodium Chloride
Other Name: 0.9% Sodium Chloride
- Post-Operative Opioid Requirement [ Time Frame: 24 hours post-operatively ]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.
- Post-Operative Pain [ Time Frame: 24 Hours Post-Operatively ]Patients will be assessed for pain using a Visual Analogue Scale (VAS) Scale at set time points after surgery (0,1,2,4,8,12,16,20,24 hours post-operatively). The Visual Analogue Scale (VAS) scale was measured on a scale of 0 - 10 (0 = no pain, 1-3 = mild, 4-6 = moderate, 7-10 = severe). Higher values on the VAS represent a worse outcome. The two rows below report: 1. the average VAS score for the least amount of pain reported per group and 2. the average VAS score of the worst amount of pain reported per group.
- Post-Operative Side Effects [ Time Frame: 24 Hours Post-Operatively ]Patients will be monitored for 24 hours post-operatively to detect the incidence of any drug or opioid-related side effects. These side effects were not considered to be adverse events.
- Time to Extubation at Emergence From Anesthesia [ Time Frame: 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 [ Time Frame: From time of entry to PACU to time to meet PACU discharge criteria, an average of 12 minutes ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01598701
|United States, Texas|
|Memorial Hermann Hospital - Texas Medical Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||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|