Study of the Efficiency of the Ketamine With Low Analgesic Doses, in Association With High Opioids, in the Treatment of the Rebels Pains, in Palliative Phase of the Cancerous Disease
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- The percentage of reduction of the daily average score of painful intensity after 4 days of treatment (to J4), with regard to the basic value to J0
Study Overview
Brief Summary
Long-term opioid therapy is commonly administered for the management of severe cancer pain. Increasing doses of opioids are titrated against effects until analgesia is achieved or intolerable adverse effects occur. Ketamine, an N-methyl-D-aspartate (NMDA) receptor antagonist, has been reported to improve analgesia in patients with uncontrolled pain receiving high doses of opioids. This study aims at determining the effectiveness of ketamine as an adjuvant to opioids in relieving cancer pain.
Detailed Description
Main objective:
To show that low analgesic doses of ketamine in intravenous infusion during 4 days associated with opioids better relieve refractory cancer pain than opioids without ketamine.
This study is a prospective study, multicenter (11 centres), consisting of 3 phases:
- a randomized controlled double blind phase of 5 days with 2 parallel groups of 38 patients each : ketamine (in association with high opioids), in intravenous injection during 4 days, versus placebo (in association with high opioids), in intravenous injection during 4 days ;
- an open-label phase of maximum 4 days, during which the ketamine Panpharma® is administered in intravenous infusion to the hospitalized patients who are still having uncontrolled pain persisting or recurrent ;
- an observational phase : starting at the discharge of the patient, of a maximal period of 6 months.The inclusion period is during 18 months, the total duration of the study is 2 years.
76 patients are expected: 38 will be treated with opioids and ketamine; 38 will be treated with opioids and a placebo.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Hospitalized cancer patients (informed and conscious of the cancer diagnostic)
- •Undergoing opioid treatment for 15 days at least
- •Refractory pain (score higher than 5 on an 10-point numerical pain rating scale)
- •Ability to score pain on a numerical pain rating scale
- •Patient written agreement
Exclusion Criteria
- •Ketamine contraindications
- •Methadone or other NMDA-antagonist treatment
- •Karnofsky index under 10
- •Pregnancy
Arms & Interventions
Ketamine
Ketamine PANFARMA
Intervention: Ketamine (Drug)
Not Ketamine
NaCl
Intervention: NaCl (Drug)
Outcomes
Primary Outcomes
The percentage of reduction of the daily average score of painful intensity after 4 days of treatment (to J4), with regard to the basic value to J0
Time Frame: 4 days
The daily average score of painful intensity being the score of painful intensity of the previous 24 hours, determined by the patient on a digital scale(ladder) validated from 0 to 10
Secondary Outcomes
- Daily sleep interference score(4 days)
- Patient satisfaction of pain relief(4 days)
- Opioids consumption(4 days)
- Patient Global Impression of Change/ Clinical Global Impression of Change(4 days)
- Evaluate the adverse effects of opioids-ketamine association versus opioids-placebo(4 days)