Effectiveness of Ketamine in Malignant Neuropathic Pain Relief (KETA-1)
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|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Recruitment Status : Withdrawn (Poor patient recruitment.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
|Condition or disease||Intervention/treatment||Phase|
|Pain, Intractable||Drug: Ketamine Drug: Placebo||Phase 3|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Low-dose Ketamine as Adjuvant Treatment to Morphine in Neuropathic Cancer Pain|
|Actual Study Start Date :||September 2013|
|Actual Primary Completion Date :||October 2016|
|Actual Study Completion Date :||October 2016|
Active Comparator: Ketamine
Ketamine 1 mg per kg per 24 hours as subcutaneous infusion via syringe driver for 48 hours.
Patients will receive either ketamine as subcutaneous infusion or placebo as subcutaneous infusion. The results will be compared with each other.
Other Name: Ketalar
Placebo Comparator: Placebo
Sodium chloride 0.9% administered as a subcutaneous infusion via syringe driver for 48 hours.
Other Name: Sodium chloride 0.9%
- 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.
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): NCT01951911
|Haukeland University Hospital|
|Bergen, Hordaland, Norway, 5021|
|Principal Investigator:||Rae F Bell, M.D. PhD.||Pain Clinic, Haukeland University Hospital, 5021 Bergen, Norway|