The Efficacy of Intravenous Acetaminophen During Perioperative Neurosurgery Period
Condition: Craniotomy; Brain Surgery
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Acetaminophen; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): Tylenol; normal saline
Intervention MeSH terms: Acetaminophen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: craniotomy; brain surgery; acetaminophen; Tylenol