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| ID | Type | Description | Link |
|---|---|---|---|
| IRB #12-409B | Other Identifier | North Shore-Long Island Jewish Health System |
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Principal Investigator left the institution
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The purpose of this study is to evaluate the use of IV acetaminophen for postoperative pain management after laparoscopic cholecystectomy to determine if its use to supplement standard of care pain management decreases the incidence of post-operative nausea and vomiting.
The recent clinical development of an intravenous (IV) acetaminophen formulation for use in the US has important implications for the management of postoperative pain given its safety profile and suitability for use in the early phase of the postoperative period. In clinical studies a significant opioid-sparing effect has been documented with a substantial percentage of patients avoiding the need for opioid rescue medication altogether. This avoidance or delay in the use of opioids has been shown to reduce undesirable side effects. It is proposed that the use of IV acetaminophen in the post anesthesia care unit (PACU) for postoperative analgesia after laparoscopic cholecystectomy will result in decreased incidence of post operative nausea and vomiting (PONV) and decreased use of narcotics.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IV Acetaminophen | Active Comparator | IV Acetaminophen administered on admission to post-anesthesia care unit |
|
| Standard of care | Active Comparator | Standard of care pain management regimen including opioids administered on admission to post-anesthesia care unit |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IV Acetaminophen | Drug | Single dose, 1000g mg infusion over 15 minutes plus standard of care pain management regimen |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Postoperative Nausea and Vomiting (PONV). | Number of participants with postoperative nausea and vomiting (PONV) will be recorded during PACU stay. PONV is defined as nausea intensity of 4 or higher on 0-10 numeric rating scale (NRS) and/or at least one episode of vomiting/retching. | 4 hours plus/minus 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Post Discharge Nausea and Vomiting (PDNV) | Number of participants reporting post discharge nausea and vomiting (PDNV) documented up to 2 days following surgery. PDNV is defined as nausea intensity of 4 or higher on 0-10 numeric rating scale (NRS) and/or at least one episode of vomiting/retching following discharge. | Up to two days following surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Requiring Rescue Analgesia for Breakthrough Pain | Number of patients requiring rescue analgesia medication during first hour of PACU stay | 1 hour following surgery |
| Narcotic Use During PACU Stay |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frank J Overdyk, MD | Northwell Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Shore University Hospital | Manhasset | New York | 11030 | United States | ||
| Long Island Jewish Medical Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | IV Acetaminophen | IV Acetaminophen administered before PACU admission IV Acetaminophen: Single dose, 1000g mg infusion over 15 minutes |
| FG001 | Standard of Care | Standard of care pain management regimen including opioids Standard of Care: without IV acetaminophen |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | IV Acetaminophen | IV Acetaminophen administered before PACU admission IV Acetaminophen: Single dose, 1000g mg infusion over 15 minutes |
| BG001 | Standard of Care | Standard of care pain management regimen including opioids Standard of Care: No IV acetaminophen |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Participants With Postoperative Nausea and Vomiting (PONV). | Number of participants with postoperative nausea and vomiting (PONV) will be recorded during PACU stay. PONV is defined as nausea intensity of 4 or higher on 0-10 numeric rating scale (NRS) and/or at least one episode of vomiting/retching. | Posted | Count of Participants | Participants | No | 4 hours plus/minus 30 minutes |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | IV Acetaminophen | IV Acetaminophen administered on admission to PACU IV Acetaminophen: Single dose, 1000g mg infusion over 15 minutes plus standard of care |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Research, Department of Anesthesiology | Northwell | 718-470-7630 | odowling@northwell.edu |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D020250 | Postoperative Nausea and Vomiting |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Standard of Care | Drug | Standard of care pain management regimen, no IV Acetaminophen, |
|
|
| Highest Pain Intensity Score Using Numeric Rating Scale (NRS) | Highest pain intensity reported during PACU stay using a 11-point (0-10) pain intensity numeric rating scale (NRS). Higher values represent higher pain intensities. | 4 hours plus/minus 30 minutes |
| Patient Satisfaction on a 5 Point Likert Scale | Number of patients very satisfied or satisfied with pain and PONV management during hospital stay | Up to one week following surgery |
| Pain Intensity Score 1 Hour Following Surgery Using Numeric Rating Scale | Pain intensity score reported by participants 1 hour following surgery using an 11-point, 0-10 Numeric Rating Scale (NRS). Higher scores indicate higher pain intensities | 1 hour following surgery |
Narcotic medication administered during PACU stay in morphine milligram equivalents
| 4 hours plus/minus 30 minutes |
| New Hyde Park |
| New York |
| 11040 |
| United States |
| Syosset Hospital | Syosset | New York | 11791 | United States |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| Secondary | Number of Participants With Post Discharge Nausea and Vomiting (PDNV) | Number of participants reporting post discharge nausea and vomiting (PDNV) documented up to 2 days following surgery. PDNV is defined as nausea intensity of 4 or higher on 0-10 numeric rating scale (NRS) and/or at least one episode of vomiting/retching following discharge. | Post-discharge follow up group. Patients not included in analysis were lost to follow up. | Posted | Count of Participants | Participants | No | Up to two days following surgery |
|
|
|
| Secondary | Highest Pain Intensity Score Using Numeric Rating Scale (NRS) | Highest pain intensity reported during PACU stay using a 11-point (0-10) pain intensity numeric rating scale (NRS). Higher values represent higher pain intensities. | Posted | Median | Inter-Quartile Range | Units on a numerical rating scale | 4 hours plus/minus 30 minutes |
|
|
|
| Secondary | Patient Satisfaction on a 5 Point Likert Scale | Number of patients very satisfied or satisfied with pain and PONV management during hospital stay | Post-discharge follow up group. Patients not included in analysis were lost to follow up. | Posted | Count of Participants | Participants | Up to one week following surgery |
|
|
|
| Secondary | Pain Intensity Score 1 Hour Following Surgery Using Numeric Rating Scale | Pain intensity score reported by participants 1 hour following surgery using an 11-point, 0-10 Numeric Rating Scale (NRS). Higher scores indicate higher pain intensities | Posted | Median | Inter-Quartile Range | Units on a numerical rating scale | 1 hour following surgery |
|
|
|
| Other Pre-specified | Number of Patients Requiring Rescue Analgesia for Breakthrough Pain | Number of patients requiring rescue analgesia medication during first hour of PACU stay | Posted | Count of Participants | Participants | 1 hour following surgery |
|
|
|
| Other Pre-specified | Narcotic Use During PACU Stay | Narcotic medication administered during PACU stay in morphine milligram equivalents | Posted | Mean | 95% Confidence Interval | Morphine milligram equivalents | 4 hours plus/minus 30 minutes |
|
|
|
| 0 |
| 52 |
| 18 |
| 52 |
| EG001 | Standard of Care | Standard of care pain management regimen including opioids administered on admission to PACU No IV acetaminophen | 0 | 53 | 23 | 53 |
| Drowziness | Nervous system disorders | Non-systematic Assessment |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D009325 | Nausea |
| D012817 | Signs and Symptoms, Digestive |
| D014839 | Vomiting |
| Aniline Compounds |
| D000588 | Amines |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |