Clinical trial · Interventional
Efficacy of Low Analgesic Doses of Ketamine Associated With Opioids in Refractory Cancer Pain Treatment
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
NCT01326325CI-TRIAL-00011630KEPALcompletedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pain | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ketamine | Drug | — | UNRESOLVED |
| NaCl | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Ketamine
- description
- Ketamine PANFARMA
- interventionNames
- Drug: Ketamine
- type
- PLACEBO_COMPARATOR
- label
- Not Ketamine
- description
- NaCl
- interventionNames
- Drug: NaCl
Primary outcomes (1)
- measure
- 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
- timeFrame
- 4 days
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (34)
- BACKGROUNDDOMINO EF, CHODOFF P, CORSSEN G. PHARMACOLOGIC EFFECTS OF CI-581, A NEW DISSOCIATIVE ANESTHETIC, IN MAN. Clin Pharmacol Ther. 1965 May-Jun;6:279-91. doi: 10.1002/cpt196563279. No abstract available. PMID 14296024
- BACKGROUNDClements JA, Nimmo WS. Pharmacokinetics and analgesic effect of ketamine in man. Br J Anaesth. 1981 Jan;53(1):27-30. doi: 10.1093/bja/53.1.27. PMID 7459184
- BACKGROUNDYamamura T, Harada K, Okamura A, Kemmotsu O. Is the site of action of ketamine anesthesia the N-methyl-D-aspartate receptor? Anesthesiology. 1990 Apr;72(4):704-10. doi: 10.1097/00000542-199004000-00021. PMID 1969718
- BACKGROUNDFranks NP, Lieb WR. Molecular and cellular mechanisms of general anaesthesia. Nature. 1994 Feb 17;367(6464):607-14. doi: 10.1038/367607a0. PMID 7509043
- BACKGROUNDJacox A, Carr DB, Payne R. New clinical-practice guidelines for the management of pain in patients with cancer. N Engl J Med. 1994 Mar 3;330(9):651-5. doi: 10.1056/NEJM199403033300926. No abstract available. PMID 7508094
- BACKGROUNDKrakowski I, Theobald S, Balp L, Bonnefoi MP, Chvetzoff G, Collard O, Collin E, Couturier M, Delorme T, Duclos R, Eschalier A, Fergane B, Larue F, Magnet M, Minello C, Navez ML, Richard A, Richard B, Rostaing-Rigattieri S, Rousselot H, Santolaria N, Torloting G, Toussaint S, Vuillemin N, Wagner JP, Fabre N; FNCLCC. Summary version of the Standards, Options and Recommendations for the use of analgesia for the treatment of nociceptive pain in adults with cancer (update 2002). Br J Cancer. 2003 Aug;89 Suppl 1(Suppl 1):S67-72. doi: 10.1038/sj.bjc.6601086. No abstract available. PMID 12915905
- BACKGROUNDRostaing-Rigattieri S, Rousselot H, Krakowski I, Theobald S, Collin E, Vuillemin N, Balp L, Torloting G, Fergane B, Richard B, Duclos R, Eschalier A, Delorme T, Minello C, Toussaint S, Richard A, Magnet M, Chvetzoff G, Larue F, Navez ML, Collard O, Bonnefoi MP, Couturier M, Santolaria N, Wagner JP, Fabre N. [Standards, options and recommendations for the use of medical analgesics for the treatment of pain arising from excess nociception in adults with cancer (update 2002): opioid analgesics with the exception of morphine by mouth and the rotation]. Bull Cancer. 2003 Aug-Sep;90(8-9):795-806. French.