Back to resultsEffect of Postoperative Single Dose of Ketamine on Pain After Mastectomy
Primary Purpose
Postoperative Pain
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ketamine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain focused on measuring Mastectomy
Eligibility Criteria
Inclusion Criteria:
- Adult women, aged 18 to 80 years old, who will undergo mastectomy.
- Willing to comply with all study procedures and be available for the duration of the study.
- Will be scheduled for elective breast surgery for oncologic indication as follows: mastectomy +/- lymph node dissection, prophylactic mastectomy, unilateral or bilateral, with immediate reconstruction
- No distant metastases.
- Subject is American Society of Anesthesiologists (ASA) physical status 1, 2, or 3.
- Subject is medically stable.
Exclusion Criteria:
- Cognitive impairment (by history) or clinical signs of altered mental status such as confusion, amnesia, disorientation, fluctuating levels of alertness, etc. that may interference with adherence to study procedures and/or participant safety.
- Past ketamine or phencyclidine misuse or abuse.
- Schizophrenia or history of psychosis.
- Known sensitivity or allergy to ketamine.
- Liver or renal insufficiency.
- History of uncontrolled hypertension, chest pain, cardiac arrythmia, stroke, head trauma, intracranial mass or hemorrhage or pressure, glaucoma, acute globe injury, uncontrolled thyroid disease, porphyria, or any other contraindication to ketamine. Use of lamotrigine, alfentanil, physostigmine, and 4-aminopyridine are contraindicated
- Pregnancy or nursing women
- BMI>35.
- Currently participating in another pain interventional trial.
- Unwillingness to give informed consent.
- Non-English speaking patients as QoR-15 and BCPQ have not been validated in all other languages
Sites / Locations
- NYU Langone Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Treatment
Control
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
Total Dosage of Opioid Use
Use and dosage will be assessed through medical records and subject reports.
Total Dosage of Opioid Use
Use and dosage will be assessed through medical records and subject reports.
Total Dosage of Opioid Use
Use and dosage will be assess through medical records and subject reports.
Total Dosage of Opioid Use
Use and dosage will be assess through medical records and subject reports.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04831736
Brief Title
Effect of Postoperative Single Dose of Ketamine on Pain After Mastectomy
Official Title
Randomized, Single-blind, Placebo-controlled Study on the Effect of Postoperative Administration of Single Dose Ketamine After Mastectomy on Pain
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
April 26, 2021 (Actual)
Primary Completion Date
March 29, 2022 (Actual)
Study Completion Date
March 29, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
Mastectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Title
Control
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Ketamine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching equal dose of saline placebo will be administered intravenously while the participant is recovering in the PACU.
Primary Outcome Measure Information:
Title
Brief Pain Inventory-short Form (BPI) Pain Severity Subscale Score
Description
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.
Time Frame
24 Hours Post-Op (Day 2)
Title
Brief Pain Inventory-short Form (BPI) Pain Severity Subscale Score
Description
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.
Time Frame
48 Hours Post-Op (Day 3)
Secondary Outcome Measure Information:
Title
Brief Pain Inventory-short Form (BPI) Pain Severity Subscale Score
Description
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.
Time Frame
Baseline (Day 0)
Title
Brief Pain Inventory-short Form (BPI) Pain Severity Subscale Score
Description
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.
Time Frame
Day 7 Post-Op (Day 8)
Title
Brief Pain Inventory-short Form (BPI) Pain Interference Subscale Score
Description
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.
Time Frame
Baseline (Day 0)
Title
Brief Pain Inventory-short Form (BPI) Pain Interference Subscale Score
Description
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.
Time Frame
Day 1 Post-Op (Day 2)
Title
Brief Pain Inventory-short Form (BPI) Pain Interference Subscale Score
Description
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.
Time Frame
Day 2 Post-Op (Day 3)
Title
Brief Pain Inventory-short Form (BPI) Pain Interference Subscale Score
Description
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.
Time Frame
Day 7 Post-Op (Day 8)
Title
Total Dosage of Opioid Use
Description
Use and dosage will be assessed through medical records and subject reports.
Time Frame
Day of Surgery (Day 1)
Title
Total Dosage of Opioid Use
Description
Use and dosage will be assessed through medical records and subject reports.
Time Frame
Day 1 Post-Op (Day 2)
Title
Total Dosage of Opioid Use
Description
Use and dosage will be assess through medical records and subject reports.
Time Frame
Day 2 Post-Op (Day 3)
Title
Total Dosage of Opioid Use
Description
Use and dosage will be assess through medical records and subject reports.
Time Frame
Day 7 Post-Op (Day 8)
Title
Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue (Short Form 7b) Daily Score
Description
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.
Time Frame
Baseline (Day 0)
Title
Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue (Short Form 7b) Daily Score
Description
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.
Time Frame
Day 1 Post-Op (Day 2)
Title
Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue (Short Form 7b) Daily Score
Description
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.
Time Frame
Day 2 Post-Op (Day 3)
Title
Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue (Short Form 7b) Daily Score
Description
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.
Time Frame
Day 7 Post-Op (Day 8)
Title
Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance (Short Form 6A) Score
Description
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.
Time Frame
Baseline (Day 0)
Title
Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance (Short Form 6A) Score
Description
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.
Time Frame
Day 7 Post-Op (Day 8)
Title
Generalized Anxiety Disorder (GAD-2) Score
Description
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.
Time Frame
Baseline (Day 0)
Title
Generalized Anxiety Disorder (GAD-2) Score
Description
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.
Time Frame
Day 7 Post-Op (Day 8)
Title
Breast Cancer Pain Questionnaire (BCPQ) - Pain Score
Description
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.
Time Frame
Day 7 Post-Op (Day 8)
Title
Quality of Recovery (QoR-15) Survey Score
Description
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.
Time Frame
Day 2 Post-Op (Day 3)
Title
Quality of Recovery (QoR-15) Survey Score
Description
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.
Time Frame
Day 7 Post-Op (Day 8)
Title
Number of Participants Who Experience Side Effects
Description
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.
Time Frame
Day of Surgery (Day 1)
Title
Number of Participants Who Experience Side Effects
Description
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.
Time Frame
Day 1 Post-Op (Day 2)
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult women, aged 18 to 80 years old, who will undergo mastectomy.
Willing to comply with all study procedures and be available for the duration of the study.
Will be scheduled for elective breast surgery for oncologic indication as follows: mastectomy +/- lymph node dissection, prophylactic mastectomy, unilateral or bilateral, with immediate reconstruction
No distant metastases.
Subject is American Society of Anesthesiologists (ASA) physical status 1, 2, or 3.
Subject is medically stable.
Exclusion Criteria:
Cognitive impairment (by history) or clinical signs of altered mental status such as confusion, amnesia, disorientation, fluctuating levels of alertness, etc. that may interference with adherence to study procedures and/or participant safety.
Past ketamine or phencyclidine misuse or abuse.
Schizophrenia or history of psychosis.
Known sensitivity or allergy to ketamine.
Liver or renal insufficiency.
History of uncontrolled hypertension, chest pain, cardiac arrythmia, stroke, head trauma, intracranial mass or hemorrhage or pressure, glaucoma, acute globe injury, uncontrolled thyroid disease, porphyria, or any other contraindication to ketamine. Use of lamotrigine, alfentanil, physostigmine, and 4-aminopyridine are contraindicated
Pregnancy or nursing women
BMI>35.
Currently participating in another pain interventional trial.
Unwillingness to give informed consent.
Non-English speaking patients as QoR-15 and BCPQ have not been validated in all other languages
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa Doan, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
IPD Sharing Time Frame
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
IPD Sharing Access Criteria
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.
Learn more about this trial
Effect of Postoperative Single Dose of Ketamine on Pain After Mastectomy
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