Ketamine and Magnesium in Post-operative Pain Control in Patients Treated With Opioids
NCT ID: NCT02940509
Last Updated: 2022-05-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE1
20 participants
INTERVENTIONAL
2017-07-01
2018-02-27
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effect of Single Dose Ketamine and Magnesium on Postoperative Pain in Patients Undergoing Bariatric Surgery
NCT02334059
Efficacy of IV Acetaminophen for Pain Management
NCT02028715
Effect of Intrathecal Magnesium Sulfate Versus Intravenous Magnesium Sulfate on Postoperative Pain After Abdominal Hysterectomy
NCT06367595
A Comparison of Intra-op Ketamine vs Placebo in Patients Having Spinal Fusion
NCT02424591
Evaluation of Ketamine and Multi-modal Analgesics
NCT02815111
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The use of intraoperative Ketamine and Magnesium is predicted to decrease postoperative pain in patients on chronic opioid therapy for management of chronic pelvic pain and will overall improve patients' postoperative experience.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Ketamine plus Magnesium sulfate
Ketamine 0.5mg/kg IV dose with 2g magnesium IV dose
Ketamine plus Magnesium sulfate
Patients will receive 2 IV infusions:
1. Ketamine (0.5mg/kg)
2. Magnesium sulfate (2g)
Placebo
Normal Saline (NaCl 0.9%)
Placebo
Patients will receive 2 IV infusions, both of NaCl 0.9%, as placebos for Ketamine and magnesium sulfate
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Ketamine plus Magnesium sulfate
Patients will receive 2 IV infusions:
1. Ketamine (0.5mg/kg)
2. Magnesium sulfate (2g)
Placebo
Patients will receive 2 IV infusions, both of NaCl 0.9%, as placebos for Ketamine and magnesium sulfate
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Patients with chronic pelvic pain defined as pain that has persisted for more than 6 months in duration which is localized to the pelvis, anterior abdominal wall, lower back or buttocks and has leads to functional disability or medical care1
3. Patients requiring opioids daily for \>1 month
4. Consenting adults age 18-80
5. American Society of Anesthesiologists (ASA) Physical Status classification II to ASA III
Exclusion Criteria
2. Chronic Kidney disease (Creatinine\>2)
3. Patients treated with methadone
4. Known allergy or adverse effect of ketamine or magnesium
5. Patient unable to give informed consent
6. Patient with limited or no English fluency
7. Uncontrolled hypertension
18 Years
80 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Milton S. Hershey Medical Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Stacey Duryea
Physician
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Stacey Duryea, DO
Role: PRINCIPAL_INVESTIGATOR
Milton S. Hershey Medical Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
STUDY00006048
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.