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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DA042985-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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The overall goal of this research is to improve perioperative pain treatment, decrease post-operative opioid consumption, diminish opioid related side effects, and reduce postop opioid prescribing (and hence opportunity for diversion, abuse, addiction, and fatal overdose).
This protocol will test the innovative, paradigm-shifting hypothesis that anesthesia for outpatient surgery with long-duration opioids (methadone), compared with conventional short-duration opioids, achieves better analgesia, with similar or diminished side effects, may reduce development of chronic postsurgical pain, improves recovery, and importantly, decreases postoperative opioid consumption and could hence diminish take-home opioid prescribing and shrink the population reservoir of unused opioids available for diversion and misuse. Two cohorts will be studied, but analyzed separately. 1) Short-stay, anticipated next-day discharge surgery (compare short-duration vs long-duration opioid), 2) Same-day discharge surgery (compare short-duration vs long-duration opioid).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Short-stay, IV methadone | Active Comparator | Anticipated next-day discharge; intraoperative and post-operative IV methadone |
|
| Short-stay, IV short-acting opioids | Active Comparator | Anticipated next-day discharge; intraoperative and post-operative IV fentanyl, sufentanil, morphine, or hydromorphone at anesthesia provider discretion |
|
| Same-day, IV methadone | Active Comparator | Intraoperative and post-operative IV methadone |
|
| Same-day, IV short-acting opioids | Active Comparator | Intraoperative and post-operative IV fentanyl, sufentanil, morphine or hydromorphone at anesthesia provider discretion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methadone | Drug | Dose is 0.15-0.3 mg/kg IV methadone HCl given intraoperatively and in the immediate post-operative period. Intraoperative methadone doses are 15 mg in "short-stay, anticipated next-day discharge" patients (10 mg if ≤55kg), and 10 mg in "same-day" surgery patients. |
| Measure | Description | Time Frame |
|---|---|---|
| Total 30 Day Post-discharge Home Opioid Use (Number of Tablets) | Based on home diary and hospital record. Number of opioid tablets from PACU discharge to postoperative day (POD) 30 for Same Day subjects, and number of opioid tablets from POD 1 to POD 30 for Short-Stay subjects. | Approximately 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Total Intraoperative Non-methadone Opioid Administration | Based on hospital record. | Approximately 12 hours |
| Total Post Anesthesia Care Unit (PACU) Opioid Administration | Based on hospital record. |
Not provided
Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Evan Kharasch, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38447097 | Derived | Kharasch ED, Schlabaugh C, Metzler E, Schultz A. Coronavirus Disease-2019 Pandemic Effects on Patient Decisions Regarding Clinical Trial Participation. Anesth Analg. 2024 Apr 1;138(4):906-908. doi: 10.1213/ANE.0000000000006783. Epub 2024 Mar 15. No abstract available. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Short-stay, IV Methadone | Anticipated next-day discharge; intraoperative and post-operative IV methadone Methadone: Dose is 0.15-0.3 mg/kg IV methadone HCl given intraoperatively and in the immediate post-operative period. Intraoperative methadone doses are 15 mg in "short-stay, anticipated next-day discharge" patients (10 mg if ≤55kg), and 10 mg in "same-day" surgery patients. |
| FG001 | Short-stay, IV Short-acting Opioids | Anticipated next-day discharge; intraoperative and post-operative IV fentanyl, sufentanil, morphine, or hydromorphone at anesthesia provider discretion Fentanyl: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)). Hydromorphone: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)). Morphine: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)). Sufentanil: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)). |
| FG002 | Same-day, IV Methadone | Intraoperative and post-operative IV methadone Methadone: Dose is 0.15-0.3 mg/kg IV methadone HCl given intraoperatively and in the immediate post-operative period. Intraoperative methadone doses are 15 mg in "short-stay, anticipated next-day discharge" patients (10 mg if ≤55kg), and 10 mg in "same-day" surgery patients. |
| FG003 | Same-day, IV Short-acting Opioids | Intraoperative and post-operative IV fentanyl, sufentanil, morphine or hydromorphone at anesthesia provider discretion Fentanyl: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)). Hydromorphone: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)). Morphine: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)). Sufentanil: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Participants who completed the study.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Short-stay, IV Methadone | Anticipated next-day discharge; intraoperative and post-operative IV methadone Methadone: Dose is 0.15-0.3 mg/kg IV methadone HCl given intraoperatively and in the immediate post-operative period. Intraoperative methadone doses are 15 mg in "short-stay, anticipated next-day discharge" patients (10 mg if ≤55kg), and 10 mg in "same-day" surgery patients. |
| 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 | Total 30 Day Post-discharge Home Opioid Use (Number of Tablets) | Based on home diary and hospital record. Number of opioid tablets from PACU discharge to postoperative day (POD) 30 for Same Day subjects, and number of opioid tablets from POD 1 to POD 30 for Short-Stay subjects. | Posted | Mean | Standard Deviation | tablets | Approximately 30 days |
|
Approximately 30 days
Not provided
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 | Short-stay, IV Methadone | Anticipated next-day discharge; intraoperative and post-operative IV methadone Methadone: Dose is 0.15-0.3 mg/kg IV methadone HCl given intraoperatively and in the immediate post-operative period. Intraoperative methadone doses are 15 mg in "short-stay, anticipated next-day discharge" patients (10 mg if ≤55kg), and 10 mg in "same-day" surgery patients. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| admission to behavioral facility | Psychiatric disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Evan Kharasch, MD, PhD | Duke University | 919-613-1154 | evan.kharasch@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 18, 2023 | Jul 30, 2024 | Prot_SAP_000.pdf |
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| 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 |
|---|---|
| D008691 | Methadone |
| D005283 | Fentanyl |
| D004091 | Hydromorphone |
| D009020 | Morphine |
| D017409 | Sufentanil |
| ID | Term |
|---|---|
| D007659 | Ketones |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Fentanyl | Drug | Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)). |
|
| Hydromorphone | Drug | Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)). |
|
| Morphine | Drug | Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)). |
|
| Sufentanil | Drug | Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)). |
|
| Approximately 2 hours |
| Total Hospital Non-methadone Opioid Administration | Based on hospital record. | Start of surgery to hospital discharge, up to 2 days |
| Total 7-day Post-PACU Discharge Home Opioid Use | Based on home diary and hospital record. Number of opioid tablets from PACU discharge to postoperative day (POD) 7 for Same Day subjects, and number of opioid tablets from POD 1 to POD 7 for Short-Stay subjects. | Up to 7 days post-PACU discharge |
| Withdrawal by Subject |
|
| BG001 | Short-stay, IV Short-acting Opioids | Anticipated next-day discharge; intraoperative and post-operative IV fentanyl, sufentanil, morphine, or hydromorphone at anesthesia provider discretion Fentanyl: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)). Hydromorphone: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)). Morphine: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)). Sufentanil: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)). |
| BG002 | Same-day, IV Methadone | Intraoperative and post-operative IV methadone Methadone: Dose is 0.15-0.3 mg/kg IV methadone HCl given intraoperatively and in the immediate post-operative period. Intraoperative methadone doses are 15 mg in "short-stay, anticipated next-day discharge" patients (10 mg if ≤55kg), and 10 mg in "same-day" surgery patients. |
| BG003 | Same-day, IV Short-acting Opioids | Intraoperative and post-operative IV fentanyl, sufentanil, morphine or hydromorphone at anesthesia provider discretion Fentanyl: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)). Hydromorphone: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)). Morphine: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)). Sufentanil: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)). |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
Anticipated next-day discharge; intraoperative and post-operative IV fentanyl, sufentanil, morphine, or hydromorphone at anesthesia provider discretion Fentanyl: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)). Hydromorphone: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)). Morphine: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)). Sufentanil: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)). |
| OG002 | Same-day, IV Methadone | Intraoperative and post-operative IV methadone Methadone: Dose is 0.15-0.3 mg/kg IV methadone HCl given intraoperatively and in the immediate post-operative period. Intraoperative methadone doses are 15 mg in "short-stay, anticipated next-day discharge" patients (10 mg if ≤55kg), and 10 mg in "same-day" surgery patients. |
| OG003 | Same-day, IV Short-acting Opioids | Intraoperative and post-operative IV fentanyl, sufentanil, morphine or hydromorphone at anesthesia provider discretion Fentanyl: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)). Hydromorphone: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)). Morphine: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)). Sufentanil: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)). |
|
|
|
| Secondary | Total Intraoperative Non-methadone Opioid Administration | Based on hospital record. | Posted | Median | Inter-Quartile Range | Milligram Morphine Equivalent (MME) | Approximately 12 hours |
|
|
|
|
| Secondary | Total Post Anesthesia Care Unit (PACU) Opioid Administration | Based on hospital record. | Posted | Median | Inter-Quartile Range | Milligram Morphine Equivalent (MME) | Approximately 2 hours |
|
|
|
|
| Secondary | Total Hospital Non-methadone Opioid Administration | Based on hospital record. | Posted | Median | Inter-Quartile Range | Milligram Morphine Equivalent (MME) | Start of surgery to hospital discharge, up to 2 days |
|
|
|
|
| Secondary | Total 7-day Post-PACU Discharge Home Opioid Use | Based on home diary and hospital record. Number of opioid tablets from PACU discharge to postoperative day (POD) 7 for Same Day subjects, and number of opioid tablets from POD 1 to POD 7 for Short-Stay subjects. | Participants with data collected. | Posted | Mean | Standard Deviation | tablets | Up to 7 days post-PACU discharge |
|
|
|
|
| 0 |
| 188 |
| 6 |
| 188 |
| 21 |
| 188 |
| EG001 | Short-stay, IV Short-acting Opioids | Anticipated next-day discharge; intraoperative and post-operative IV fentanyl, sufentanil, morphine, or hydromorphone at anesthesia provider discretion Fentanyl: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)). Hydromorphone: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)). Morphine: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)). Sufentanil: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)). | 1 | 188 | 6 | 188 | 17 | 188 |
| EG002 | Same-day, IV Methadone | Intraoperative and post-operative IV methadone Methadone: Dose is 0.15-0.3 mg/kg IV methadone HCl given intraoperatively and in the immediate post-operative period. Intraoperative methadone doses are 15 mg in "short-stay, anticipated next-day discharge" patients (10 mg if ≤55kg), and 10 mg in "same-day" surgery patients. | 0 | 205 | 10 | 205 | 29 | 205 |
| EG003 | Same-day, IV Short-acting Opioids | Intraoperative and post-operative IV fentanyl, sufentanil, morphine or hydromorphone at anesthesia provider discretion Fentanyl: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)). Hydromorphone: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)). Morphine: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)). Sufentanil: Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)). | 0 | 205 | 11 | 205 | 16 | 205 |
| anastomotic leak | Gastrointestinal disorders | Non-systematic Assessment |
|
| appendicitis | Gastrointestinal disorders | Non-systematic Assessment |
|
| bladder spasms | Renal and urinary disorders | Non-systematic Assessment |
|
| bleeding | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| bleeding ulcer | Gastrointestinal disorders | Non-systematic Assessment |
|
| carbon monoxide poisoning | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| febrile neutropenia | Immune system disorders | Non-systematic Assessment |
|
| fever | General disorders | Non-systematic Assessment |
|
| colovesicular fistula | Gastrointestinal disorders | Non-systematic Assessment |
|
| ileus | Gastrointestinal disorders | Non-systematic Assessment |
|
| seizures | Nervous system disorders | Non-systematic Assessment |
|
| sepsis | Infections and infestations | Non-systematic Assessment |
|
| urinary retention | Renal and urinary disorders | Non-systematic Assessment |
|
| urosepsis | Infections and infestations | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | Non-systematic Assessment |
|
| Epistaxis | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Infection | Infections and infestations | Non-systematic Assessment |
|
| NSTEMI | Cardiac disorders | Non-systematic Assessment |
|
| Post-operative Hemorrhage | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Vagal response to laryngoscopy | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Wound Dehiscence | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Wound Infection | Infections and infestations | Non-systematic Assessment |
|
| cesarean delivery | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
|
| hemorrhagic cyst | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| metastasis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| pain | General disorders | Non-systematic Assessment |
|
| pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| shortness of breath | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| spontaneous labor | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
|
| DVT | Vascular disorders | Non-systematic Assessment |
|
| abdominal distension | Gastrointestinal disorders | Non-systematic Assessment |
|
| abnormal ECG | Investigations | Non-systematic Assessment |
|
| apnea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| bladder spasms | Renal and urinary disorders | Non-systematic Assessment |
|
| car accident | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| catheter placement | Surgical and medical procedures | Non-systematic Assessment |
|
| elevated creatinine | Renal and urinary disorders | Non-systematic Assessment |
|
| epistaxis | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| flu like symptoms | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| hives | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| hypertension | Cardiac disorders | Non-systematic Assessment |
|
| hypotension | Cardiac disorders | Non-systematic Assessment |
|
| hypoventilation | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| hypoxemia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| ileus | Gastrointestinal disorders | Non-systematic Assessment |
|
| intraoperative decrease in compliance | Cardiac disorders | Non-systematic Assessment |
|
| mouse bite | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| pain | General disorders | Non-systematic Assessment |
|
| pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| seroma | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| substance induced psychosis | Nervous system disorders | Non-systematic Assessment |
|
| urinary retention | Renal and urinary disorders | Non-systematic Assessment |
|
| intraoperative bradycardia | Cardiac disorders | Non-systematic Assessment |
|
| RUE weakness | General disorders | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | Non-systematic Assessment |
|
| abscess | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| alcohol intoxication | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| bladder defect | Renal and urinary disorders | Non-systematic Assessment |
|
| bloody nasal discharge | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| bronchitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| constipation | Gastrointestinal disorders | Non-systematic Assessment |
|
| convulsive-like movement | Nervous system disorders | Non-systematic Assessment |
|
| diverticulitis | Gastrointestinal disorders | Non-systematic Assessment |
|
| diverticulosis | Gastrointestinal disorders | Non-systematic Assessment |
|
| eyelid swelling | Eye disorders | Non-systematic Assessment |
|
| hand injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| headache | Nervous system disorders | Non-systematic Assessment |
|
| heart palpitations | Cardiac disorders | Non-systematic Assessment |
|
| heart racing | Cardiac disorders | Non-systematic Assessment |
|
| hematoma | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| leg cramps | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| levator spasms | Gastrointestinal disorders | Non-systematic Assessment |
|
| mononucleosis | Infections and infestations | Non-systematic Assessment |
|
| nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| non-epileptic seizures | Nervous system disorders | Non-systematic Assessment |
|
| pruritis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| seizure | Nervous system disorders | Non-systematic Assessment |
|
| seizure-like activity | Nervous system disorders | Non-systematic Assessment |
|
| shortness of breath | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| shoulder injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| somnolence | General disorders | Non-systematic Assessment |
|
| tachycardia | Cardiac disorders | Non-systematic Assessment |
|
| vaginal bleeding | Reproductive system and breast disorders | Non-systematic Assessment |
|
| ventilatory depression | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
| wound dressing | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D006571 |
| Heterocyclic Compounds |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| Other |
| Other |
| Other |
| Other |