Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Dose-response of Ketamine in Patient Controlled Analgesia in Orthopaedic Surgery Patients (DoseRespKeta)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02994173
Recruitment Status : Recruiting
First Posted : December 15, 2016
Last Update Posted : February 4, 2019
Sponsor:
Collaborators:
University of Turku
Helsinki University
Information provided by (Responsible Party):
Turku University Hospital

Brief Summary:
To study the multimodal protocol combining adjunct ketamine with oxycodone in intravenous patient-controlled analgesia bolus dosing and effects in patients scheduled for posterolateral lumbar spine fusion with bilateral transpedicular screw instrumentation

Condition or disease Intervention/treatment Phase
Pain, Postoperative Drug: Oxycodone Drug: S-Ketamine 0.25 Drug: S-Ketamine 0.5 Drug: S-Ketamine 0.75 Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dose Response Study of Patient Controlled Analgesia (PCA) of S-ketamine in Orthopaedic Spine Surgery Patients
Actual Study Start Date : February 1, 2017
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Arm Intervention/treatment
Active Comparator: Placebo
Oxycodone 1 mg / ml alone
Drug: Oxycodone
Current clinical practice, used as a control in this study
Other Name: Oxanest

Active Comparator: Ketamine 0.25
Oxycodone 1 mg / ml + S-ketamine 0.25 mg / ml (ratio 1:0.25)
Drug: S-Ketamine 0.25
dosage
Other Name: Ketanest-S

Active Comparator: Ketamine 0.5
Oxycodone 1 mg / ml + S-ketamine 0.5 mg / ml (ratio 1:0.5)
Drug: S-Ketamine 0.5
dosage
Other Name: Ketanest-S

Active Comparator: Ketamine 0.75
Oxycodone 1 mg / ml + S-ketamine 0.75 mg / ml (ratio 1:0.75)
Drug: S-Ketamine 0.75
dosage
Other Name: Ketanest-S




Primary Outcome Measures :
  1. Change in opioid consumption (mg) postoperatively [ Time Frame: 24 and 72 hours ]
    Change from baseline opioid consumption (mg) postoperatively at 24 and 72 hours


Secondary Outcome Measures :
  1. Change in numerical rating scale (NRS 0-10) [ Time Frame: 24 and 72 hours ]
    Change from baseline NRS value postoperatively at 24 and 72 hours



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 20 - 75 years of age
  • Scheduled for elective posterolateral lumbar spine fusion with bilateral transpedicular screw instrumentation under general anaesthesia.
  • Written informed consent from the participating patient

Exclusion Criteria:

  • A previous history of intolerance to the study drug or related compounds and additives
  • Concomitant drug therapy with opioids or strong CYP3A4 or CYP2B6 inductor(s) or inhibitor(s) 2 weeks prior to study.
  • Patients younger than 20 years and older than 75 years.
  • BMI > 35, sleep apnoea, any other sleep disorder or condition that requires treatment with continuous positive airway pressure or automatic positive airway pressure device.
  • Existing significant liver or kidney disease
  • History of ischemic heart disease or conduction disturbance
  • History of alcoholism, drug abuse, psychological or other emotional problems that are likely to invalidate informed consent
  • Donation of blood for 4 weeks prior and during the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02994173


Contacts
Layout table for location contacts
Contact: Marko Peltoniemi, MD, PhD +3582 3130000 marko.peltoniemi@tyks.fi
Contact: Teijo Saari, MD, PhD +358 2 3132967 teisaa@utu.fi

Locations
Layout table for location information
Finland
Perioperative Services, Intensive Care and Pain Therapy, Turku University Hospital Recruiting
Turku, Finland, 20521
Contact: Marko Marko, MD, PhD    +3582313000    marko.peltoniemi@tyks.fi   
Contact: Teijo I Saari, MD, PhD    +35823132967    teisaa@utu.fi   
Principal Investigator: Marko Peltoniemi, MD, PhD         
Sponsors and Collaborators
Turku University Hospital
University of Turku
Helsinki University
Investigators
Layout table for investigator information
Principal Investigator: Marko Peltoniemi, MD, PhD Perioperative Services, Intensive Care and Pain Therapy, Turku University Hospital

Layout table for additonal information
Responsible Party: Turku University Hospital
ClinicalTrials.gov Identifier: NCT02994173     History of Changes
Other Study ID Numbers: T281/2016
First Posted: December 15, 2016    Key Record Dates
Last Update Posted: February 4, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Ketamine
Oxycodone
Esketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Antidepressive Agents
Psychotropic Drugs