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
This is a randomized, single blinded, placebo-controlled trial to study the effectiveness of a subanesthetic dose (0.6mg/kg) of ketamine versus placebo (saline) on postoperative pain on adult women undergoing mastectomy.
The objective of the study is to examine the effect of a subanesthetic dose (0.6mg/kg) of ketamine vs. saline control on postoperative pain in subjects who have undergone mastectomy.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental |
| |
| Control | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketamine | Drug | Ketamine at a dose of 0.6 mg/kg will be administered intravenously (IV) while the participant is recovering in the PACU. The study drug will be administered over at least 30 minutes at one time point and will be administered after subject has been deemed to be stable (hemodynamically stable, awake) by the study team on POD 0. |
| Measure | Description | Time Frame |
|---|---|---|
| Brief Pain Inventory-short Form (BPI) Pain Severity Subscale Score | BPI Pain Severity Subscale consists of 4 questions (asking to rate pain). Each question is answered on a scale 0 (no pain) to 10 (pain as bad as you can imagine). The total range of score is 0-40; the higher the score, the worse the pain. | 24 Hours Post-Op (Day 2) |
| Brief Pain Inventory-short Form (BPI) Pain Severity Subscale Score | BPI Pain Severity Subscale consists of 4 questions (asking to rate pain). Each question is answered on a scale 0 (no pain) to 10 (pain as bad as you can imagine). The total range of score is 0-40; the higher the score, the worse the pain. | 48 Hours Post-Op (Day 3) |
| Measure | Description | Time Frame |
|---|---|---|
| Brief Pain Inventory-short Form (BPI) Pain Severity Subscale Score | BPI Pain Severity Subscale is a 4-item questionnaire asking participants to rate pain. Each question is answered on a scale 0 (no pain) to 10 (pain as bad as you can imagine). The total range of score is 0-40; the higher the score, the worse the pain. | Baseline (Day 0) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Lisa Doan, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | New York | New York | 10016 | United States |
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
The investigator who proposed to use the data will have access to the data upon reasonable request. Requests should be directed to lisa.doan@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Treatment | Ketamine: Ketamine at a dose of 0.6 mg/kg will be administered intravenously (IV) while the participant is recovering in the PACU. The study drug will be administered over at least 30 minutes at one time point and will be administered after subject has been deemed to be stable (hemodynamically stable, awake) by the study team on POD 0. |
| FG001 | Control | Placebo: Matching equal dose of saline placebo will be administered intravenously while the participant is recovering in the PACU. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Treatment | Ketamine: Ketamine at a dose of 0.6 mg/kg will be administered intravenously (IV) while the participant is recovering in the PACU. The study drug will be administered over at least 30 minutes at one time point and will be administered after subject has been deemed to be stable (hemodynamically stable, awake) by the study team on POD 0. |
| 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 | Brief Pain Inventory-short Form (BPI) Pain Severity Subscale Score | BPI Pain Severity Subscale consists of 4 questions (asking to rate pain). Each question is answered on a scale 0 (no pain) to 10 (pain as bad as you can imagine). The total range of score is 0-40; the higher the score, the worse the pain. | Posted | Mean | Standard Deviation | score on a scale | 24 Hours Post-Op (Day 2) |
|
7 Days
Participants self-reported adverse events. Side effects reported using the 7-item psycho-behavioral questionnaire (see Outcome Measures #24 and #25) were not considered to be Adverse Events or Serious Adverse Events.
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 | Treatment | Ketamine: Ketamine at a dose of 0.6 mg/kg will be administered intravenously (IV) while the participant is recovering in the PACU. The study drug will be administered over at least 30 minutes at one time point and will be administered after subject has been deemed to be stable (hemodynamically stable, awake) by the study team on POD 0. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lisa Doan, MD | NYU Langone Health | 212-201-1004 | Lisa.Doan@nyulangone.org |
Not provided
| 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 | Nov 8, 2021 | Mar 28, 2023 | Prot_SAP_000.pdf |
Not provided
Not provided
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 |
|---|---|
| D007649 | Ketamine |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Placebo | Drug | Matching equal dose of saline placebo will be administered intravenously while the participant is recovering in the PACU. |
|
| Brief Pain Inventory-short Form (BPI) Pain Severity Subscale Score |
BPI Pain Severity Subscale is a 4-item questionnaire asking participants to rate pain. Each question is answered on a scale 0 (no pain) to 10 (pain as bad as you can imagine). The total range of score is 0-40; the higher the score, the worse the pain. |
| Day 7 Post-Op (Day 8) |
| Brief Pain Inventory-short Form (BPI) Pain Interference Subscale Score | BPI Pain Interference Subscale is a 7-item questionnaire asking participants to describe how pain has interfered during activities. Each question is answered on a scale 0 (does not interfere) to 10 (completely interferes). The total range of score is 0-70; the higher the score, the worse the interference. | Baseline (Day 0) |
| Brief Pain Inventory-short Form (BPI) Pain Interference Subscale Score | BPI Pain Interference Subscale is a 7-item questionnaire asking participants to describe how pain has interfered during activities. Each question is answered on a scale 0 (does not interfere) to 10 (completely interferes). The total range of score is 0-70; the higher the score, the worse the interference. | Day 1 Post-Op (Day 2) |
| Brief Pain Inventory-short Form (BPI) Pain Interference Subscale Score | BPI Pain Interference Subscale is a 7-item questionnaire asking participants to describe how pain has interfered during activities. Each question is answered on a scale 0 (does not interfere) to 10 (completely interferes). The total range of score is 0-70; the higher the score, the worse the interference. | Day 2 Post-Op (Day 3) |
| Brief Pain Inventory-short Form (BPI) Pain Interference Subscale Score | BPI Pain Interference Subscale is a 7-item questionnaire asking participants to describe how pain has interfered during activities. Each question is answered on a scale 0 (does not interfere) to 10 (completely interferes). The total range of score is 0-70; the higher the score, the worse the interference. | Day 7 Post-Op (Day 8) |
| Total Dosage of Opioid Use | Use and dosage will be assessed through medical records and subject reports. | Day of Surgery (Day 1) |
| Total Dosage of Opioid Use | Use and dosage will be assessed through medical records and subject reports. | Day 1 Post-Op (Day 2) |
| Total Dosage of Opioid Use | Use and dosage will be assess through medical records and subject reports. | Day 2 Post-Op (Day 3) |
| Total Dosage of Opioid Use | Use and dosage will be assess through medical records and subject reports. | Day 7 Post-Op (Day 8) |
| Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue (Short Form 7b) Daily Score | The PROMIS Fatigue Short Form consists of 7 questions evaluating the frequency of fatigue. Each question is answered with a score from 1 (never) to 5 (always). The raw score is the sum of each item and ranges from 7-35. Raw scores are converted to T-scores ranging from 31 to 81.4, with a standard deviation of 10. Higher T-scores indicate higher frequency of fatigue. | Baseline (Day 0) |
| Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue (Short Form 7b) Daily Score | The PROMIS Fatigue Short Form consists of 7 questions evaluating the frequency of fatigue. Each question is answered with a score from 1 (never) to 5 (always). The raw score is the sum of each item and ranges from 7-35. Raw scores are converted to T-scores ranging from 31 to 81.4, with a standard deviation of 10. Higher T-scores indicate higher frequency of fatigue. | Day 1 Post-Op (Day 2) |
| Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue (Short Form 7b) Daily Score | The PROMIS Fatigue Short Form consists of 7 questions evaluating the frequency of fatigue. Each question is answered with a score from 1 (never) to 5 (always). The raw score is the sum of each item and ranges from 7-35. Raw scores are converted to T-scores ranging from 31 to 81.4, with a standard deviation of 10. Higher T-scores indicate higher frequency of fatigue. | Day 2 Post-Op (Day 3) |
| Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue (Short Form 7b) Daily Score | The PROMIS Fatigue Short Form consists of 7 questions evaluating the frequency of fatigue. Each question is answered with a score from 1 (never) to 5 (always). The raw score is the sum of each item and ranges from 7-35. Raw scores are converted to T-scores ranging from 31 to 81.4, with a standard deviation of 10. Higher T-scores indicate higher frequency of fatigue. | Day 7 Post-Op (Day 8) |
| Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance (Short Form 6A) Score | The PROMIS Sleep Disturbance Short Form consists of 6 items assessing sleep disturbance. Each question is answered with a score of 1-5 (varies). The raw score is the sum of each item and ranges from 6-30. The raw score is converted to a T-score ranging from 31.7 to 76.1, with a standard deviation of 10. Higher T-scores indicate greater sleep disturbance. | Baseline (Day 0) |
| Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance (Short Form 6A) Score | The PROMIS Sleep Disturbance Short Form consists of 6 items assessing sleep disturbance. Each question is answered with a score of 1-5 (varies). The raw score is the sum of each item and ranges from 6-30. The raw score is converted to a T-score ranging from 31.7 to 76.1, with a standard deviation of 10. Higher T-scores indicate greater sleep disturbance. | Day 7 Post-Op (Day 8) |
| Generalized Anxiety Disorder (GAD-2) Score | GAD-2 consists of 2 items and measures how often one has been bothered by anxiety-related problems. Each is answered with a score of 0 (not at all) to 3 (nearly every day). The total range of score is 0-6; the higher the score, the more frequent one is bothered by anxiety. | Baseline (Day 0) |
| Generalized Anxiety Disorder (GAD-2) Score | GAD-2 consists of 2 items and measures how often one has been bothered by anxiety-related problems. Each is answered with a score of 0 (not at all) to 3 (nearly every day). The total range of score is 0-6; the higher the score, the more frequent one is bothered by anxiety. | Day 7 Post-Op (Day 8) |
| Breast Cancer Pain Questionnaire (BCPQ) - Pain Score | If the patient reports pain in the area of the breast, armpit, side of the body, or arm on the side of operation, the patient will be asked to report level of pain (0 is no pain and 10 is the worst pain imaginable). For each location, the total score is 0-10; the higher the score, the worse the pain. The total score is the sum of responses from each location. | Day 7 Post-Op (Day 8) |
| Quality of Recovery (QoR-15) Survey Score | Part A of QoR-15 consists of 10 conditions. Based on how the patient has been feeling in the last 24 hours, they will respond to each condition using an 11-point Likert scale ranging from 0 to 10, where 0 is none of the time [poor] and 10 is all of the time [excellent]). The total range of score for Part A is 0-100; the higher the score, the better the participant has been feeling. Part B consists of 5 symptoms. The patient will indicate whether they have experienced each symptom over the last 24 hours using an 11-point Likert scale ranging from 10 to 0, where 10 is none of the time [excellent] and 0 is all of the time [poor]). The total range of score for Part B is 0-50; the higher the score, the better the participant has been feeling. The total score is the sum of of scores from Parts A and B. Total scores range from 0-150; the higher the score, the better the participant has been feeling. | Day 2 Post-Op (Day 3) |
| Quality of Recovery (QoR-15) Survey Score | Part A of QoR-15 consists of 10 conditions. Based on how the patient has been feeling in the last 24 hours, they will respond to each condition using an 11-point Likert scale ranging from 0 to 10, where 0 is none of the time [poor] and 10 is all of the time [excellent]). The total range of score for Part A is 0-100; the higher the score, the better the participant has been feeling. Part B consists of 5 symptoms. The patient will indicate whether they have experienced each symptom over the last 24 hours using an 11-point Likert scale ranging from 10 to 0, where 10 is none of the time [excellent] and 0 is all of the time [poor]). The total range of score for Part B is 0-50; the higher the score, the better the participant has been feeling. The total score is the sum of of scores from Parts A and B. Scores range from 0-150; the higher the score, the better the participant has been feeling. | Day 7 Post-Op (Day 8) |
| Number of Participants Who Experience Side Effects | Side effects are calculated using a 7-item psycho-behavioral questionnaire. Participants indicate whether they have experienced any of the listed side effects of ketamine. The side effects listed on the questionnaire are not considered to be Adverse Events or Serious Adverse Events. | Day of Surgery (Day 1) |
| Number of Participants Who Experience Side Effects | Side effects are calculated using a 7-item psycho-behavioral questionnaire. Participants indicate whether they have experienced any of the listed side effects. The side effects listed on the questionnaire are not considered to be Adverse Events or Serious Adverse Events. | Day 1 Post-Op (Day 2) |
| BG001 |
| Control |
Placebo: Matching equal dose of saline placebo will be administered intravenously while the participant is recovering in the PACU. |
| 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 |
|
| Region of Enrollment | Number | participants |
|
Placebo: Matching equal dose of saline placebo will be administered intravenously while the participant is recovering in the PACU. |
|
|
| Primary | Brief Pain Inventory-short Form (BPI) Pain Severity Subscale Score | BPI Pain Severity Subscale consists of 4 questions (asking to rate pain). Each question is answered on a scale 0 (no pain) to 10 (pain as bad as you can imagine). The total range of score is 0-40; the higher the score, the worse the pain. | Posted | Mean | Standard Deviation | score on a scale | 48 Hours Post-Op (Day 3) |
|
|
|
| Secondary | Brief Pain Inventory-short Form (BPI) Pain Severity Subscale Score | BPI Pain Severity Subscale is a 4-item questionnaire asking participants to rate pain. Each question is answered on a scale 0 (no pain) to 10 (pain as bad as you can imagine). The total range of score is 0-40; the higher the score, the worse the pain. | Posted | Mean | Standard Deviation | score on a scale | Baseline (Day 0) |
|
|
|
| Secondary | Brief Pain Inventory-short Form (BPI) Pain Severity Subscale Score | BPI Pain Severity Subscale is a 4-item questionnaire asking participants to rate pain. Each question is answered on a scale 0 (no pain) to 10 (pain as bad as you can imagine). The total range of score is 0-40; the higher the score, the worse the pain. | Posted | Mean | Standard Deviation | score on a scale | Day 7 Post-Op (Day 8) |
|
|
|
| Secondary | Brief Pain Inventory-short Form (BPI) Pain Interference Subscale Score | BPI Pain Interference Subscale is a 7-item questionnaire asking participants to describe how pain has interfered during activities. Each question is answered on a scale 0 (does not interfere) to 10 (completely interferes). The total range of score is 0-70; the higher the score, the worse the interference. | Posted | Mean | Standard Deviation | score on a scale | Baseline (Day 0) |
|
|
|
| Secondary | Brief Pain Inventory-short Form (BPI) Pain Interference Subscale Score | BPI Pain Interference Subscale is a 7-item questionnaire asking participants to describe how pain has interfered during activities. Each question is answered on a scale 0 (does not interfere) to 10 (completely interferes). The total range of score is 0-70; the higher the score, the worse the interference. | Posted | Mean | Standard Deviation | score on a scale | Day 1 Post-Op (Day 2) |
|
|
|
| Secondary | Brief Pain Inventory-short Form (BPI) Pain Interference Subscale Score | BPI Pain Interference Subscale is a 7-item questionnaire asking participants to describe how pain has interfered during activities. Each question is answered on a scale 0 (does not interfere) to 10 (completely interferes). The total range of score is 0-70; the higher the score, the worse the interference. | Posted | Mean | Standard Deviation | score on a scale | Day 2 Post-Op (Day 3) |
|
|
|
| Secondary | Brief Pain Inventory-short Form (BPI) Pain Interference Subscale Score | BPI Pain Interference Subscale is a 7-item questionnaire asking participants to describe how pain has interfered during activities. Each question is answered on a scale 0 (does not interfere) to 10 (completely interferes). The total range of score is 0-70; the higher the score, the worse the interference. | Posted | Mean | Standard Deviation | score on a scale | Day 7 Post-Op (Day 8) |
|
|
|
| Secondary | Total Dosage of Opioid Use | Use and dosage will be assessed through medical records and subject reports. | Posted | Mean | Standard Deviation | oral morphine equivalent (mg) | Day of Surgery (Day 1) |
|
|
|
| Secondary | Total Dosage of Opioid Use | Use and dosage will be assessed through medical records and subject reports. | Posted | Mean | Standard Deviation | oral morphine equivalent (mg) | Day 1 Post-Op (Day 2) |
|
|
|
| Secondary | Total Dosage of Opioid Use | Use and dosage will be assess through medical records and subject reports. | Posted | Mean | Standard Deviation | oral morphine equivalent (mg) | Day 2 Post-Op (Day 3) |
|
|
|
| Secondary | Total Dosage of Opioid Use | Use and dosage will be assess through medical records and subject reports. | Posted | Mean | Standard Deviation | oral morphine equivalent (mg) | Day 7 Post-Op (Day 8) |
|
|
|
| Secondary | Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue (Short Form 7b) Daily Score | The PROMIS Fatigue Short Form consists of 7 questions evaluating the frequency of fatigue. Each question is answered with a score from 1 (never) to 5 (always). The raw score is the sum of each item and ranges from 7-35. Raw scores are converted to T-scores ranging from 31 to 81.4, with a standard deviation of 10. Higher T-scores indicate higher frequency of fatigue. | Posted | Mean | Standard Deviation | T-score | Baseline (Day 0) |
|
|
|
| Secondary | Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue (Short Form 7b) Daily Score | The PROMIS Fatigue Short Form consists of 7 questions evaluating the frequency of fatigue. Each question is answered with a score from 1 (never) to 5 (always). The raw score is the sum of each item and ranges from 7-35. Raw scores are converted to T-scores ranging from 31 to 81.4, with a standard deviation of 10. Higher T-scores indicate higher frequency of fatigue. | Posted | Mean | Standard Deviation | T-score | Day 1 Post-Op (Day 2) |
|
|
|
| Secondary | Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue (Short Form 7b) Daily Score | The PROMIS Fatigue Short Form consists of 7 questions evaluating the frequency of fatigue. Each question is answered with a score from 1 (never) to 5 (always). The raw score is the sum of each item and ranges from 7-35. Raw scores are converted to T-scores ranging from 31 to 81.4, with a standard deviation of 10. Higher T-scores indicate higher frequency of fatigue. | Posted | Mean | Standard Deviation | T-score | Day 2 Post-Op (Day 3) |
|
|
|
| Secondary | Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue (Short Form 7b) Daily Score | The PROMIS Fatigue Short Form consists of 7 questions evaluating the frequency of fatigue. Each question is answered with a score from 1 (never) to 5 (always). The raw score is the sum of each item and ranges from 7-35. Raw scores are converted to T-scores ranging from 31 to 81.4, with a standard deviation of 10. Higher T-scores indicate higher frequency of fatigue. | Posted | Mean | Standard Deviation | T-score | Day 7 Post-Op (Day 8) |
|
|
|
| Secondary | Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance (Short Form 6A) Score | The PROMIS Sleep Disturbance Short Form consists of 6 items assessing sleep disturbance. Each question is answered with a score of 1-5 (varies). The raw score is the sum of each item and ranges from 6-30. The raw score is converted to a T-score ranging from 31.7 to 76.1, with a standard deviation of 10. Higher T-scores indicate greater sleep disturbance. | Posted | Mean | Standard Deviation | T-score | Baseline (Day 0) |
|
|
|
| Secondary | Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance (Short Form 6A) Score | The PROMIS Sleep Disturbance Short Form consists of 6 items assessing sleep disturbance. Each question is answered with a score of 1-5 (varies). The raw score is the sum of each item and ranges from 6-30. The raw score is converted to a T-score ranging from 31.7 to 76.1, with a standard deviation of 10. Higher T-scores indicate greater sleep disturbance. | Posted | Mean | Standard Deviation | T-score | Day 7 Post-Op (Day 8) |
|
|
|
| Secondary | Generalized Anxiety Disorder (GAD-2) Score | GAD-2 consists of 2 items and measures how often one has been bothered by anxiety-related problems. Each is answered with a score of 0 (not at all) to 3 (nearly every day). The total range of score is 0-6; the higher the score, the more frequent one is bothered by anxiety. | Posted | Mean | Standard Deviation | score on a scale | Baseline (Day 0) |
|
|
|
| Secondary | Generalized Anxiety Disorder (GAD-2) Score | GAD-2 consists of 2 items and measures how often one has been bothered by anxiety-related problems. Each is answered with a score of 0 (not at all) to 3 (nearly every day). The total range of score is 0-6; the higher the score, the more frequent one is bothered by anxiety. | Posted | Mean | Standard Deviation | score on a scale | Day 7 Post-Op (Day 8) |
|
|
|
| Secondary | Breast Cancer Pain Questionnaire (BCPQ) - Pain Score | If the patient reports pain in the area of the breast, armpit, side of the body, or arm on the side of operation, the patient will be asked to report level of pain (0 is no pain and 10 is the worst pain imaginable). For each location, the total score is 0-10; the higher the score, the worse the pain. The total score is the sum of responses from each location. | Posted | Mean | Standard Deviation | score on a scale | Day 7 Post-Op (Day 8) |
|
|
|
| Secondary | Quality of Recovery (QoR-15) Survey Score | Part A of QoR-15 consists of 10 conditions. Based on how the patient has been feeling in the last 24 hours, they will respond to each condition using an 11-point Likert scale ranging from 0 to 10, where 0 is none of the time [poor] and 10 is all of the time [excellent]). The total range of score for Part A is 0-100; the higher the score, the better the participant has been feeling. Part B consists of 5 symptoms. The patient will indicate whether they have experienced each symptom over the last 24 hours using an 11-point Likert scale ranging from 10 to 0, where 10 is none of the time [excellent] and 0 is all of the time [poor]). The total range of score for Part B is 0-50; the higher the score, the better the participant has been feeling. The total score is the sum of of scores from Parts A and B. Total scores range from 0-150; the higher the score, the better the participant has been feeling. | Posted | Mean | Standard Deviation | score on a scale | Day 2 Post-Op (Day 3) |
|
|
|
| Secondary | Quality of Recovery (QoR-15) Survey Score | Part A of QoR-15 consists of 10 conditions. Based on how the patient has been feeling in the last 24 hours, they will respond to each condition using an 11-point Likert scale ranging from 0 to 10, where 0 is none of the time [poor] and 10 is all of the time [excellent]). The total range of score for Part A is 0-100; the higher the score, the better the participant has been feeling. Part B consists of 5 symptoms. The patient will indicate whether they have experienced each symptom over the last 24 hours using an 11-point Likert scale ranging from 10 to 0, where 10 is none of the time [excellent] and 0 is all of the time [poor]). The total range of score for Part B is 0-50; the higher the score, the better the participant has been feeling. The total score is the sum of of scores from Parts A and B. Scores range from 0-150; the higher the score, the better the participant has been feeling. | Posted | Mean | Standard Deviation | score on a scale | Day 7 Post-Op (Day 8) |
|
|
|
| Secondary | Number of Participants Who Experience Side Effects | Side effects are calculated using a 7-item psycho-behavioral questionnaire. Participants indicate whether they have experienced any of the listed side effects of ketamine. The side effects listed on the questionnaire are not considered to be Adverse Events or Serious Adverse Events. | Posted | Count of Participants | Participants | Day of Surgery (Day 1) |
|
|
|
| Secondary | Number of Participants Who Experience Side Effects | Side effects are calculated using a 7-item psycho-behavioral questionnaire. Participants indicate whether they have experienced any of the listed side effects. The side effects listed on the questionnaire are not considered to be Adverse Events or Serious Adverse Events. | Posted | Count of Participants | Participants | Day 1 Post-Op (Day 2) |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Control | Placebo: Matching equal dose of saline placebo will be administered intravenously while the participant is recovering in the PACU. | 0 | 15 | 0 | 15 | 0 | 15 |
Not provided
Not provided
Not provided
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |