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| Name | Class |
|---|---|
| Cadence Pharmaceuticals | INDUSTRY |
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This is a research study to determine if giving acetaminophen intravenously in hte operating room will decrease the number of patients who require additional pain medicine, such as morphine, after surgery in the recovery room.
Primary Specific Aim: To determine if adding an intraoperative dose of intravenous acetaminphen to usual and customary analgesics during ambulatory surgery impacts the proportion of patients remaining opioid-free in the post-anesthesia recovery room.
Hypothesis: Adding an intraoperative dose of intravenous acetaminophen to usual and customary analgesics during ambulatory surgery increases the proportion of patients remaining opioid-free in the post-anesthesia recovery room.
Secondary Specific Aim: To determine if adding an intraoperative dose of intravenous acetaminophen to usual and customary analgesics during amublatory surgery impacts the required doses of additional perioperative analgesics.
Hypothesis: Adding an intraoperative dose of intravenous acetaminophen to usual and customary analgesics during ambulatory surgery decreases the required doses of additional analgesics in both the operating room and post-anesthesia recovery room.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IV Acetaminophen | Active Comparator | Intraoperative IV acetaminophen administered |
|
| IV Placebo | Placebo Comparator | Intraoperative IV normal saline administered |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravenous acetaminophen | Drug | Acetaminophen 1000 mg administered over 15 minutes intravenously as soon as feasible intraoperatively. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary endpoint is the difference in proportions of patients from each treatment group who avoid using any opioids following anesthesia emergence until recovery room discharge. | Day of Surgery |
| Measure | Description | Time Frame |
|---|---|---|
| A secondary endpoint for this investigation will be the total dose of fentanyl administered to the patient. | Day of Surgery | |
| A secondary outcome for this investigation will be the total dose of morphine administered to the patient. | Day of Surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian M Ilfeld, M.D., M.S. | University of California, San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSD Medical Center (Hillcrest and Thornton) | San Diego | California | 92103 | United States |
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| Intravenous placebo | Drug | Normal saline administered over 15 minutes intravenously as soon as feasible intraoperatively. |
|
| A secondary outcome for this investigation will be the total dose of ibuprophen administered to the patient. | Day of Surgery |
| A secondary outcome measure for this investigation will be the total dose of oxycodone administered to the patient. | Day of Surgery |
| A secondary outcome measure will be any surgeon-administered local anesthetics used for wound infiltration. | Day of Surgery |
| A secondary outcome measure for this study will be any recovery-room anti-emetics administered to the patient. | Day of Surgery |
| Patients will be asked at time of PACU discharge, "Overall, how would you rate the study treatments?" Responses will be on 0 to 3 scale where 0=poor and 3=excellent. | Day of Surgery |
| Patients will be asked at time of PACU discharge, "Overall, how would you rate the level of pain relief from study medication?" Responses will be on 0 to 3 scale where 0=poor and 3=excellent. | Day of Surgery |
| Adverse events | Up to one year postoperative |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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