Pain, Postoperative
Conditions
Brief summary
The current study proposes to examine whether there is a significant difference in patient outcomes related to the administration route of preoperative Acetaminophen. Specifically, the study will compare outcomes of surgical patients who receive IV Acetaminophen with surgical patients who receive oral Acetaminophen.
Detailed description
This study will use a randomized, double-blind, controlled design with two arms: Arm 1: Scheduled IV Acetaminophen and PO placebo provided preoperatively Arm 2: Scheduled PO Acetaminophen and IV placebo provided preoperatively 120 patients will be randomized 1:1 into Arm 1 or Arm 2. All other care, except route of preoperative Acetaminophen, will follow standard care procedures. The following outcome measures will be collected: postoperative pain, postoperative opioid medication administration, postoperative nausea and vomiting, occurrence of respiratory depression postoperatively, occurrence of administration of reversal agent postoperatively, length of stay in recovery room, patient satisfaction with pain control.
Interventions
DRUGIV Acetaminophen
IV Acetaminophen 1000mg in 100mL normal saline once pre-operatively
DRUGPO Acetaminophen
Acetaminophen PO 1000mg once pre-operatively
DRUGPO Placebo
PO placebo capsule compounded to match PO Acetaminophen capsule
DRUGIV Solution Placebo
This will serve as the placebo for the IV Acetaminophen intervention
Sponsors
TriHealth Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Only pharmacy staff will have randomization scheme and be aware of whether patient received oral Acetaminophen with IV placebo OR if the patient received IV Acetaminophen with oral placebo
Intervention model description
This study will use a randomized, double-blind, placebo controlled design with two arms.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years old or older * Admitted to Bethesda Butler Main Perioperative Services for an outpatient surgical procedure performed under general anesthesia
Exclusion criteria
* Allergy to Acetaminophen * Lactose intolerance or lactose allergy (placebo capsules contain lactose) * Hepatic disease * Having taken a product containing acetaminophen within 6 hours of scheduled surgery time * Pregnant * Weight less than 50kg * Opioid addiction - admits to current opioid addiction and/or substance abuse disorder, and/or currently in treatment for opioid addiction or substance abuse * Emergent or on-call procedures * Inpatient surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Reported Pain | through study visit, less than 24 hours | Pain measured from 0 (no pain) to 10 (worst pain) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Received Opioid Administration in PACU | through study visit, less than 24 hours | Number of Participants who Received Opioid Administration in PACU |
| Number of Participants Who Experienced Postoperative Nausea and Vomiting | through study visit, less than 24 hours | Did patient experience negative effects of pain medication (postoperative nausea and vomiting) |
| Length of Stay | through study visit, less than 24 hours | Minutes from entering PACU to end of Phase II |
| Patient Satisfaction | up to 2 days after surgery | Patient reported satisfaction with pain control on a scale of 1 (extremely unsatisfied) to 10 (extremely satisfied) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm 1: IV Acetaminophen Group Patients randomized to Arm 1 will receive IV Acetaminophen 1000mg in 100mL NS once and a PO placebo pill preoperatively
IV Acetaminophen: IV Acetaminophen 1000mg in 100mL normal saline once pre-operatively
PO Placebo: PO placebo capsule compounded to match PO Acetaminophen capsule | 60 |
| Arm 2: PO Acetaminophen Group Patients randomized to Arm 2 will receive IV normal saline 100mL once and Acetaminophen 1000 mg PO once preoperatively
PO Acetaminophen: Acetaminophen PO 1000mg once pre-operatively
IV Solution Placebo: This will serve as the placebo for the IV Acetaminophen intervention | 60 |
| Total | 120 |
Baseline characteristics
| Characteristic | Arm 2: PO Acetaminophen Group | Total | Arm 1: IV Acetaminophen Group |
|---|---|---|---|
| Age, Continuous | 46.28 years STANDARD_DEVIATION 16.84 | 45.83 years STANDARD_DEVIATION 16.28 | 45.37 years STANDARD_DEVIATION 15.82 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 60 participants | 120 participants | 60 participants |
| Sex: Female, Male Female | 35 Participants | 72 Participants | 37 Participants |
| Sex: Female, Male Male | 25 Participants | 48 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 60 | 0 / 60 |
| other Total, other adverse events | 0 / 60 | 0 / 60 |
| serious Total, serious adverse events | 0 / 60 | 0 / 60 |
Outcome results
Primary
Patient Reported Pain
Pain measured from 0 (no pain) to 10 (worst pain)
Time frame: through study visit, less than 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1: IV Acetaminophen Group | Patient Reported Pain | 4.12 score on a scale | Standard Deviation 3.092 |
| Arm 2: PO Acetaminophen Group | Patient Reported Pain | 4.37 score on a scale | Standard Deviation 3.226 |
Secondary
Length of Stay
Minutes from entering PACU to end of Phase II
Time frame: through study visit, less than 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1: IV Acetaminophen Group | Length of Stay | 88.25 minutes | Standard Deviation 26.651 |
| Arm 2: PO Acetaminophen Group | Length of Stay | 92.88 minutes | Standard Deviation 29.911 |
Secondary
Number of Participants Who Experienced Postoperative Nausea and Vomiting
Did patient experience negative effects of pain medication (postoperative nausea and vomiting)
Time frame: through study visit, less than 24 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm 1: IV Acetaminophen Group | Number of Participants Who Experienced Postoperative Nausea and Vomiting | 8 Participants |
| Arm 2: PO Acetaminophen Group | Number of Participants Who Experienced Postoperative Nausea and Vomiting | 6 Participants |
Secondary
Number of Participants Who Received Opioid Administration in PACU
Number of Participants who Received Opioid Administration in PACU
Time frame: through study visit, less than 24 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm 1: IV Acetaminophen Group | Number of Participants Who Received Opioid Administration in PACU | 31 Participants |
| Arm 2: PO Acetaminophen Group | Number of Participants Who Received Opioid Administration in PACU | 34 Participants |
Secondary
Patient Satisfaction
Patient reported satisfaction with pain control on a scale of 1 (extremely unsatisfied) to 10 (extremely satisfied)
Time frame: up to 2 days after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1: IV Acetaminophen Group | Patient Satisfaction | 9.45 score on a scale | Standard Deviation 0.95 |
| Arm 2: PO Acetaminophen Group | Patient Satisfaction | 9.77 score on a scale | Standard Deviation 0.528 |