Efficacy of Low Analgesic Doses of Ketamine Associated With Opioids in Refractory Cancer Pain Treatment

NCT01326325 | Completed Phase 3

• 1 other identifier: P081242
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

Cancer; Refractory pain; Uncontrolled pain; Ketamine

Outcome Measures

Primary Outcomes (1)

• 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

  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

  4 days

Secondary Outcomes (5)

• Patient Global Impression of Change/ Clinical Global Impression of Change

  4 days

• Daily sleep interference score

  4 days

• Patient satisfaction of pain relief

  4 days

• Opioids consumption

  4 days

• Evaluate the adverse effects of opioids-ketamine association versus opioids-placebo

  4 days

Study Arms (2)

Ketamine

EXPERIMENTAL

Ketamine PANFARMA

Drug: Ketamine

Not Ketamine

PLACEBO COMPARATOR

NaCl

Drug: NaCl

Interventions

Ketamine DRUG

Drip continues of ketamine in intravenous injection included posology enters 0,5mg/kg /day and 2mg/kg/day during 4 days

Ketamine

NaCl DRUG

Drip continues of NaCl 0,9% in intravenous injection during 4 days

Not Ketamine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Ketamine contraindications
• Methadone or other NMDA-antagonist treatment
• Karnofsky index under 10
• Pregnancy

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Center of Evaluation and Treatment of the pain - Saint-Antoine Hospital

Paris, Île-de-France Region, 75012, France

Location

Related Publications (34)

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MeSH Terms

Conditions

Pain; Neoplasms; Pain, Intractable

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Sylvie ROSTAING-RIGATTIERI, MD

  Center of Evaluation and Treatment of the pain - Saint-Antoine Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2011
• First Posted: March 30, 2011
• Study Start: July 1, 2011
• Primary Completion: February 1, 2013
• Study Completion: June 1, 2013
• Last Updated: August 7, 2013

Record last verified: 2013-08

Locations

FR (1)