Pain Clinical Trial
Official title:
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
This study will evaluate the benefit of lidocaine perfusion in cancer related visceral pain resistant to morphinics. It is an efficacy study in adults and children and a randomized prospective study.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 6 Years to 70 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
France | Institut Gustave-Roussy | Villejuif |
Lead Sponsor | Collaborator |
---|---|
Gustave Roussy, Cancer Campus, Grand Paris |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | continuous intravenous perfusion for 6 days | ||
Secondary | To confirm the tolerance of the lidocaine |
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