Phase 4
N=140
The Efficacy of Intravenous Acetaminophen During Perioperative Neurosurgery Period
Craniotomy · Brain Surgery
Bottom Line
View on ClinicalTrials.gov: NCT01739699 ↗Enrolled (actual)
140
Serious AEs
0.0%
Results posted
Nov 2021
Primary outcome: Primary: Opioid Requirement After Surgery — 10; 4 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Acetaminophen (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Endeavor Health
- Primary completion
- Aug 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Opioid Requirement After Surgery |
10; 4 | — |
| SECONDARY Time to Rescue Medication in Both Groups |
22; 37 | — |
| SECONDARY Amount of Rescue Medication in PACU in Both Groups |
0.5; 0.5 | — |
| SECONDARY Median Difference in ICU Length of Stay/Hospital Length of Stay Between Both Groups |
71.75; 75.5; 26; 28 | — |
| SECONDARY Number of Participants Who Had a Successful Neurologic Exams Between Intervention and Placebo Group as Determined by a Neurosurgical Provider by Answering Either Yes or No |
57; 61; 63; 64; 60; 60 | — |
| SECONDARY Median Difference in Temperature Between Intervention and Placebo Groups |
36.6; 36.7; 36.7; 36.8; 36.7; 36.8 | — |
| SECONDARY Sedation Scores Measured by Richmand-Agitation-Sedation Scale (RASS) Every 8 Hours for 24 Hours in Both Groups |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Pain VAS Scores (1-100) Every 8 Hours for 24 Hours in Both Groups |
35; 50; 30; 45; 30; 30 | — |
| SECONDARY # of Participants With Delirium Measured by a Positive CAM-ICU Every 8 Hours for 24 Hours in Both Groups- |
1; 0; 0; 0; 0; 0 | — |
| SECONDARY Median Satisfaction Scores on a Verbal Score From 1(Not Satisfied at All) to 100 (Very Satisfied) |
87.5; 80 | — |
Summary
This is a prospective randomized double blinded trial study involving 128 patients undergoing any craniotomy procedure at Evanston Hospital. The patients will be randomized by the sealed envelope technique. The anesthesiologist and nurses who will be administering the placebo or intravenous acetaminophen will be blinded to the group in which patients are assigned.
The following general perioperative data will be recorded: patient information/preoperative data, procedural information, postoperative information, and overall satisfaction of pain management at 24 hours after surgery.
Based on a pilot study (N-20) we expect that 25% of the placebo treated patients will require no opioids in the first 24 hour postoperative period. With the use of intravenous acetaminophen, it is hypothesized that the number of patients that do not require opioids in the first 24 hours after surgery will double.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01739699). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.