Clinical trial NCT01739699
Conditions: Craniotomy Brain Surgery
Keywords: craniotomy brain surgery acetaminophen Tylenol
Sponsor: Endeavor Health
Start date: 2012-01-01; Completion date: 2017-01-20
Enrollment: 140 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief 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.

Detailed description:
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 information will be recorded for each patient enrolled in this study:

* Patient information/Preoperative Data

  * Age, sex, height, weight,
  * Disease specific information
  * Primary diagnosis
  * Pertinent medical history
  * Medications
  * Pertinent changes in patient status
* Procedural information

  * Operation type
  * Preoperative anesthetic medications
  * Induction meds, intra-operative anesthetic meds, and post-operative anesthetic meds
  * Duration of Surgery and Intubation
  * Amount of dilaudid equivalent narcotics
* Postoperative Information

  * Amount of narcotics administered in the PACU
  * Amount of narcotics administered in the first 24 hour postoperative period
  * Amount of non-narcotic analgesics administered in the first 24 hour postoperative period
  * Time to first rescue analgesic in the PACU
  * Amount of first rescue medication recorded
  * Assessment of Pain Intensity at T0.5 (30min into PACU stay) and T24 (24 hours after end of surgery) (A 10-cm VAS scale will be used and labeled no pain at its left terminus and worst pain imaginable at its right terminus)
  * Temperature in degrees centigrade every 8 hours for 24hours.
  * CAM-ICU is performed by ICU nurses to detect delirium in patients every 8 hours and will be documented on a data collection sheet for the first 24 hours
  * RASS is a sedation scoring system that is used in our ICU and is documented every 8 hours by ICU nursing. We will record the RASS score for the first 24 hours on a data collection sheet as documented by the ICU nurse.
  * Overall satisfaction score at 24 hrs. "Overall satisfaction with pain management" (verbal rating score: scale 1 - 100)

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.

Arms: arm 1: Subjects will receive 1000mg of intravenous acetaminophen every 6 hours for 24 hours beginning with dural closure. arm 2: Subjects will receive 100cc of normal saline every 6 hours for 24 hours beginning at dural closure.
Interventions: intervention 1: Acetaminophen intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents: