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Benefit of Lidocaine Perfusion in Cancer Related Visceral Pain Resistant to Morphinics: Efficacy Study in Adults and Children. Randomized Prospective Study With Direct Individual Benefit


Phase 3
6 Years
70 Years
Open (Enrolling)
Both
Cancer, Pain

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Trial Information

Benefit of Lidocaine Perfusion in Cancer Related Visceral Pain Resistant to Morphinics: Efficacy Study in Adults and Children. Randomized Prospective Study With Direct Individual Benefit


Inclusion Criteria:



- Patients suffering from cancer of any type, at any stage, hospitalized at the
Institut Gustave Roussy

- Aged from 6 to 14 years old (group A) and from 15 to 70 years old (adults)

- Presenting visceral pain due to neurotoxic chemotherapy, due to the tumoral mass or
to peritoneal carcinosis

- Pain resistant to morphinic treatment

Exclusion Criteria:

- Cardiac troubles, clinical cardiac insufficiency, or history of myocardial infarction
(MI) of less than 3 months

- Neurological: non-controlled epilepsy, encephalopathy, or dementia

- Severe hepatic insufficiency

- Severe renal insufficiency

- Respiratory insufficiency

- Patients having surgery or in postoperative period

- Known deficit in G6PD, alanine exposure, or sulphamide treatment

- Porphyria

- Weight > 80 kg

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Outcome Measure:

To determine prospectively the lidocaine efficacy in 2 types of patient populations with cancer (group A: children from 6 to 14 years old and group B: adults from 15 to 70 years old)

Outcome Time Frame:

continuous intravenous perfusion for 6 days

Principal Investigator

Philippe Poulain, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Gustave Roussy, Cancer Campus, Grand Paris

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

LIDODOULABDO

NCT ID:

NCT00181012

Start Date:

May 2005

Completion Date:

Related Keywords:

  • Cancer
  • Pain
  • Cancer Related Visceral Pain Resistant to Morphinics

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