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Effectiveness of Ketamine in Malignant Neuropathic Pain Relief (KETA-1)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01951911
Recruitment Status : Withdrawn (Poor patient recruitment. Vast majority of the patients have exclusions criteria)
First Posted : September 27, 2013
Last Update Posted : July 11, 2017
Sponsor:
Information provided by (Responsible Party):
Haukeland University Hospital

Tracking Information
First Submitted Date  ICMJE September 24, 2013
First Posted Date  ICMJE September 27, 2013
Last Update Posted Date July 11, 2017
Actual Study Start Date  ICMJE September 2013
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 6, 2017)
Change in pain intensity compared to baseline. [ Time Frame: 5 days ]
Significant reduction in cancer pain intensity will be defined as at least 30% reduction in Numeric Rating Scale (NRS) score compared to baseline.
Original Primary Outcome Measures  ICMJE
 (submitted: September 26, 2013)
Change in pain intensity compared to baseline. Significant reduction in pain intensity will be defined as at least 30% reduction in Numeric Rating Scale (NRS) score compared to baseline. [ Time Frame: 5 days ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effectiveness of Ketamine in Malignant Neuropathic Pain Relief
Official Title  ICMJE Low-dose Ketamine as Adjuvant Treatment to Morphine in Neuropathic Cancer Pain
Brief Summary To see whether the addition of low-dose ketamine to a subcutaneous morphine infusion improves analgesia in patients with neuropathic cancer pain.
Detailed Description

Patients with cancer pain judged to have a neuropathic component and receiving pain treatment with a subcutaneous infusion of morphine will be included in a randomized, double blind, placebo-controlled, crossover study. All patients will be recruited from hospital wards (Haukeland University Hospital, Bergen). In the case of patient withdrawal or dropout, new patients will be recruited so that the total number of patients completing the study will be 20. Data from patients not completing the study will solely be used to provide information about adverse effects.

The basic treatment with subcutaneous morphine infusion will be supplemented with a separate subcutaneous infusion of ketamine 1 mg/kg/ 24 hours or NaCl 9 mg/ml (placebo).

After 48 hours (phase 1) there will be a "wash-out" period of minimum 10 hours to minimize carryover effects before the treatment is replaced by the alternative treatment for a further 48 hours (phase 2) in a standard crossover design. The treatment duration is based on ketamine's short plasma half-life which is less than 2 hours after initial equilibration.

Pain intensity (using NRS) will be recorded at rest and on movement x 4 daily. Rescue medication in the form of morphine subcutaneous bolus may be given to the patient as required. There will be a" lockout" time of 1 hour which means that the rescue dose of morphine can be repeated every 60 minutes if necessary, providing the patient is awake and has a respiratory rate of 8 or more per minute.Randomization will be performed by Haukeland University Hospital Pharmacy. The study drug/ placebo will also be prepared by the hospital pharmacy according to a standard instruction.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Pain, Intractable
Intervention  ICMJE
  • Drug: Ketamine
    Patients will receive either ketamine as subcutaneous infusion or placebo as subcutaneous infusion. The results will be compared with each other.
    Other Name: Ketalar
  • Drug: Placebo
    Other Name: Sodium chloride 0.9%
Study Arms  ICMJE
  • Active Comparator: Ketamine
    Ketamine 1 mg per kg per 24 hours as subcutaneous infusion via syringe driver for 48 hours.
    Intervention: Drug: Ketamine
  • Placebo Comparator: Placebo
    Sodium chloride 0.9% administered as a subcutaneous infusion via syringe driver for 48 hours.
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: July 6, 2017)
0
Original Estimated Enrollment  ICMJE
 (submitted: September 26, 2013)
20
Actual Study Completion Date  ICMJE October 2016
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Age 18-70 years. In-patient. Cancer pain judged to have a neuropathic component. Clinically normal renal and hepatic function. Able to cooperate and understand information. Worst pain at rest or on movement 5 or more (NRS 0-10). Pain currently treated with continuous subcutaneous morphine infusion. The daily morphine dose is 48mg or more per 24 hours and a 30% increase in the daily dose has not provided sufficient pain relief.

Not treated with ketamine during the last 48 hours prior to inclusion.

-

Exclusion Criteria:

Reduced renal or hepatic function. Suspicion of morphine toxicity (sedation, hallucination, myoclonus, increasing pain).

Increased intracranial pressure (suspicion of cerebral metastases) or cerebral metastases.

Unable to cooperate/ understand information. Worst pain at rest or on movement less than 5 on NRS. Current treatment with other opioids than morphine. The patient is undergoing radiotherapy in the pain area, or has received radiotherapy in the pain area within the last four weeks.

Changes in the use of analgesics (paracetamol, NSAIDS), adjuvant drugs (antidepressants, antiepileptic, corticosteroids, muscle relaxants) or their dosages less than 2 days prior to inclusion or during the study period.

Pregnant and lactating women. Any situation in which an increase in blood pressure would constitute a hazard. Acute intermittent porphyria. Psychiatric illness, epilepsy, alcoholism, glaucoma. Hypersensitivity to any of the drugs ingredients. Current treatment with ketamine.

-

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01951911
Other Study ID Numbers  ICMJE 2012/539
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Haukeland University Hospital
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Haukeland University Hospital
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Rae F Bell, M.D. PhD. Pain Clinic, Haukeland University Hospital, 5021 Bergen, Norway
PRS Account Haukeland University Hospital
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP