Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of the study is to evaluate post-op pain requirements in patients undergoing hip or knee replacement surgery who perioperatively receive either Oral acetaminophen or IV acetaminophen
Subjects will be randomized to receive perioperative dosing of either:
Subject pain levels and post-operative opioid use will be tracked for up to 24 hours after surgery.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral acetaminophen | Active Comparator | Subjects receive 2 capsules each containing Tylenol 500 mg caplets. The test article administration will be initiated 60 minutes (± 15 minutes) prior to the scheduled surgery start time. |
|
| IV acetaminophen | Active Comparator | Subjects receive Ofirmev 1000 mg in 100 ml Normal Saline IV infusion. The test article will be given perioperatively at the discretion of the attending anesthesiologist. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral acetaminophen | Drug | Subjects randomized to the Oral acetaminophen arm will receive 2 Tylenol 500mg capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving Oral acetaminophen will also receive 100ml of IV Normal Saline similar to the delivery method of the IV acetaminophen arm. The Normal Saline IV placebo will be given not as an intervention but rather as a method to maintain study integrity. |
| Measure | Description | Time Frame |
|---|---|---|
| Total Post-operative Use of Opioids | Post-operative use of opioids, measured in morphine milligram equivalent (MME) units | During post-op period up to 24 hrs after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Patient-rated Pain in the Post-operative Period | Patient-rated pain in the post-operative period was collected using a 10-point visual analog scale (VAS). A score of 0 indicates no pain; higher scores indicate greater pain. Minimum score for each VAS measurement is 0; Maximum score for each VAS measurement is 10. VAS scores were averaged for each patient. | Standard-of-care post-op assessment intervals during post-op period up to 24 hrs after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative Nausea and Vomiting | During post-op period up to 24 hrs after surgery | |
| Time to First Ambulation - 10 Feet | During post-op period up to 24 hours after surgery | |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sidney (Skip) Hickman, RPh | Kettering Health Network | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kettering Medical Center | Kettering | Ohio | 45429 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Oral Acetaminophen | Subjects receive 2 capsules each containing Tylenol 500 mg caplets. The test article administration will be initiated 60 minutes (± 15 minutes) prior to the scheduled surgery start time. Oral acetaminophen: Subjects randomized to the Oral acetaminophen arm will receive 2 Tylenol 500mg capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving Oral acetaminophen will also receive 100ml of IV Normal Saline similar to the delivery method of the IV acetaminophen arm. The Normal Saline IV placebo will be given not as an intervention but rather as a method to maintain study integrity. |
| FG001 | IV Acetaminophen | Subjects receive Ofirmev 1000 mg in 100 ml Normal Saline IV infusion. The test article will be given perioperatively at the discretion of the attending anesthesiologist. IV acetaminophen: Subjects randomized to the IV acetaminophen arm will receive Ofirmev 1000mg in 100ml Normal Saline IV plus 2 placebo capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving IV acetaminophen will also receive 2 placebo capsules similar to the delivery method of the oral acetaminophen arm. The placebo capsules will be given not as an intervention but rather as a method to maintain study integrity. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Oral Acetaminophen | Subjects receive 2 capsules each containing Tylenol 500 mg caplets. The test article administration will be initiated 60 minutes (± 15 minutes) prior to the scheduled surgery start time. Oral acetaminophen: Subjects randomized to the Oral acetaminophen arm will receive 2 Tylenol 500mg capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving Oral acetaminophen will also receive 100ml of IV Normal Saline similar to the delivery method of the IV acetaminophen arm. The Normal Saline IV placebo will be given not as an intervention but rather as a method to maintain study integrity. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Total Post-operative Use of Opioids | Post-operative use of opioids, measured in morphine milligram equivalent (MME) units | Posted | Median | Inter-Quartile Range | Morphine milligram equivalents (MME) | During post-op period up to 24 hrs after surgery |
|
AE/SAE monitoring started at first study drug dose and ended when subjects were discharged from the Post-Anesthesia Care Unit. The time period varied among subjects but was never more than 24 hours total.
Since both the PO and IV forms of the study drug are FDA approved, both are being used within approved labeling, and the study is not being conducted under an Investigational New Drug (IND) application, only events that meet Kettering Health Network's criteria for reporting within the institution's S.A.F.E. reporting system will be reported as SAEs or UPs.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Oral Acetaminophen | Subjects receive 2 capsules each containing Tylenol 500 mg caplets. The test article administration will be initiated 60 minutes (± 15 minutes) prior to the scheduled surgery start time. Oral acetaminophen: Subjects randomized to the Oral acetaminophen arm will receive 2 Tylenol 500mg capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving Oral acetaminophen will also receive 100ml of IV Normal Saline similar to the delivery method of the IV acetaminophen arm. The Normal Saline IV placebo will be given not as an intervention but rather as a method to maintain study integrity. |
Not provided
Not provided
Single hospital, limited to two types of surgical patient. No standard protocol for assessing pain. Oral acetaminophen administered earlier than IV per hospital protocol.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Skip Hickman, RPH | Kettering Health Network | (937) 762-1339 | skip.hickman@ketteringhealth.org |
Not provided
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
Not provided
Not provided
| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| IV acetaminophen | Drug | Subjects randomized to the IV acetaminophen arm will receive Ofirmev 1000mg in 100ml Normal Saline IV plus 2 placebo capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving IV acetaminophen will also receive 2 placebo capsules similar to the delivery method of the oral acetaminophen arm. The placebo capsules will be given not as an intervention but rather as a method to maintain study integrity. |
|
|
| Time to First Rescue Opioid (PRN Order) |
| During post-op period up to 24 hrs after surgery |
| BG001 | IV Acetaminophen | Subjects receive Ofirmev 1000 mg in 100 ml Normal Saline IV infusion. The test article will be given perioperatively at the discretion of the attending anesthesiologist. IV acetaminophen: Subjects randomized to the IV acetaminophen arm will receive Ofirmev 1000mg in 100ml Normal Saline IV plus 2 placebo capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving IV acetaminophen will also receive 2 placebo capsules similar to the delivery method of the oral acetaminophen arm. The placebo capsules will be given not as an intervention but rather as a method to maintain study integrity. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Taking medications for chronic pain | Count of Participants | Participants |
|
| Oxford score (hip or knee as appropriate) | 12-item ordinal scales. Each item ranges from 0 (high impairment) to 4 (no impairment). Total score ranges from 0-48 with following interpretation: 0-19: May indicate severe arthritis. 20-29: May indicate moderate to severe arthritis. 30-39: May indicate mild to moderate arthritis. 40-48: May indicate satisfactory joint function. | Mean | Standard Deviation | units on a scale |
|
| Body mass index | In the study data, BMI ranged from 19 (minimum) to 56 (maximum). | Median | Inter-Quartile Range | lb/in^2x703 |
|
| Diabetes | Count of Participants | Participants |
|
| Stroke | Count of Participants | Participants |
|
| Type of surgery | Count of Participants | Participants |
|
| Pre-operative opioid | Count of Participants | Participants |
|
| Pre-operative Celecoxib | Count of Participants | Participants |
|
| Pre-operative Pregabalin | Count of Participants | Participants |
|
| Intra-operative total opioid | Median | Inter-Quartile Range | morphine milligram equivalents (MME) |
|
| Intra-operative Ketorolac | Count of Participants | Participants |
|
| Intra-operative Bupivacaine Liposome Injectable Suspension | Count of Participants | Participants |
|
| OG001 | IV Acetaminophen | Subjects receive Ofirmev 1000 mg in 100 ml Normal Saline IV infusion. The test article will be given perioperatively at the discretion of the attending anesthesiologist. IV acetaminophen: Subjects randomized to the IV acetaminophen arm will receive Ofirmev 1000mg in 100ml Normal Saline IV plus 2 placebo capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving IV acetaminophen will also receive 2 placebo capsules similar to the delivery method of the oral acetaminophen arm. The placebo capsules will be given not as an intervention but rather as a method to maintain study integrity. |
|
|
| Secondary | Patient-rated Pain in the Post-operative Period | Patient-rated pain in the post-operative period was collected using a 10-point visual analog scale (VAS). A score of 0 indicates no pain; higher scores indicate greater pain. Minimum score for each VAS measurement is 0; Maximum score for each VAS measurement is 10. VAS scores were averaged for each patient. | Posted | Median | Inter-Quartile Range | Visual analog pain scale (0-10) | Standard-of-care post-op assessment intervals during post-op period up to 24 hrs after surgery |
|
|
|
| Other Pre-specified | Post-operative Nausea and Vomiting | Posted | Count of Participants | Participants | During post-op period up to 24 hrs after surgery |
|
|
|
| Other Pre-specified | Time to First Ambulation - 10 Feet | Posted | Median | Inter-Quartile Range | Hours | During post-op period up to 24 hours after surgery |
|
|
|
| Other Pre-specified | Time to First Rescue Opioid (PRN Order) | Posted | Median | Inter-Quartile Range | Minutes | During post-op period up to 24 hrs after surgery |
|
|
|
| Post-Hoc | Post-Anesthesia Care Unit (PACU) Length of Stay, Hours | PACU length of stay was calculated as (PACU discharge moment - PACU admit moment). PACU length of stay is reported in hours. | Posted | Median | Inter-Quartile Range | Hours | PACU admission time until PACU discharge time |
|
|
|
| Post-Hoc | Hospital Length of Stay (LOS) | Total hospital length of stay was calculated as (hospital discharge moment - hospital admission moment). Hospital length of stay is reported in hours. | Posted | Median | Inter-Quartile Range | Hours | Pre-op admission to hospital discharge |
|
|
|
| 0 |
| 241 |
| 0 |
| 241 |
| 0 |
| 241 |
| EG001 | IV Acetaminophen | Subjects receive Ofirmev 1000 mg in 100 ml Normal Saline IV infusion. The test article will be given perioperatively at the discretion of the attending anesthesiologist. IV acetaminophen: Subjects randomized to the IV acetaminophen arm will receive Ofirmev 1000mg in 100ml Normal Saline IV plus 2 placebo capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving IV acetaminophen will also receive 2 placebo capsules similar to the delivery method of the oral acetaminophen arm. The placebo capsules will be given not as an intervention but rather as a method to maintain study integrity. | 0 | 245 | 0 | 245 | 0 | 245 |
Not provided
Not provided
Not provided
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| Aniline Compounds |
| D000588 | Amines |