Pain
Conditions
Brief summary
The purpose of the study is to determine the efficacy of IV acetaminophen when administered to neurosurgical patients at the beginning and end of their surgery. If the result is improved pain control with less opioid consumption postoperatively, then those patients may also experience less opioid related side effects such as nausea/vomiting, pruritus, and sedation. While numerous other studies have failed to show a benefit of IV acetaminophen after neurosurgical procedures, we are studying the administration of 1 g in two doses over the course of the operation.
Interventions
DRUGAcetaminophen
Acetaminophen 1 g intravenous given at the beginning and end of surgery.
DRUGPlacebo
Placebo to match acetaminophen given at the beginning and end of surgery.
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Intervention model description
Patients selected for this study were being treated for Moyamoya disease and required two operations, scheduled 1-2 weeks apart. With random assignment, patients were administered 1 gram of intravenous acetaminophen at the beginning and end of surgery, and placebo during the other operation.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with a diagnosis of bilateral moyamoya disease scheduled for bilateral external-carotid to internal-carotid bypass surgery to be done in two stages.
Exclusion criteria
* Allergy or history of reaction to acetaminophen. Patients with liver disease. Anyone not able to provide informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative Opioid Consumption | Up to 24 hours post-operative | From nursing records how much opioid was administered to each patient post-operatively. Opioid use was measured in micrograms (ug) of fentanyl. |
| Post-operative Pain | Up to 24 hours post-operative | Patients were asked to rate their pain on a scale of 1 to 10, with 1 being least pain, and 10 being most pain. Pain was assessed continually once per hour during the post-operative period and the average pain score calculated per participant. The average of the participants' average scores is presented for each group. |
Secondary
| Measure | Time frame |
|---|---|
| Count of Participants Requiring Anti-emetic Administration | Up to 24 hours post-operative |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants Patients were administered intravenous acetaminophen (1 g IV) twice in one surgery and placebo to match in the other. Patients were randomly assigned to acetaminophen first or placebo first. | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 6 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 12 Participants |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 25 | 2 / 25 |
| other Total, other adverse events | 0 / 25 | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 |
Outcome results
Primary
Post-operative Opioid Consumption
From nursing records how much opioid was administered to each patient post-operatively. Opioid use was measured in micrograms (ug) of fentanyl.
Time frame: Up to 24 hours post-operative
Population: Participants who completed both interventions were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Acetaminophen | Post-operative Opioid Consumption | 228 ug | Standard Deviation 125 |
| Placebo | Post-operative Opioid Consumption | 312 ug | Standard Deviation 165 |
Primary
Post-operative Pain
Patients were asked to rate their pain on a scale of 1 to 10, with 1 being least pain, and 10 being most pain. Pain was assessed continually once per hour during the post-operative period and the average pain score calculated per participant. The average of the participants' average scores is presented for each group.
Time frame: Up to 24 hours post-operative
Population: Participants who completed both interventions were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Acetaminophen | Post-operative Pain | Post-operative hour 0 to 12 | 3.4 units on a scale | Standard Deviation 2.6 |
| Acetaminophen | Post-operative Pain | Post-operative hour 13 to 24 | 2.7 units on a scale | Standard Deviation 2.5 |
| Acetaminophen | Post-operative Pain | Post-operative hour 0 to 24 | 3.1 units on a scale | Standard Deviation 2.4 |
| Placebo | Post-operative Pain | Post-operative hour 0 to 12 | 3.8 units on a scale | Standard Deviation 1.8 |
| Placebo | Post-operative Pain | Post-operative hour 13 to 24 | 2.6 units on a scale | Standard Deviation 1.8 |
| Placebo | Post-operative Pain | Post-operative hour 0 to 24 | 3.2 units on a scale | Standard Deviation 1.7 |
Secondary
Count of Participants Requiring Anti-emetic Administration
Time frame: Up to 24 hours post-operative
Population: Participants who completed both interventions were included in the analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Acetaminophen | Count of Participants Requiring Anti-emetic Administration | 20 Participants |
| Placebo | Count of Participants Requiring Anti-emetic Administration | 20 Participants |