Ketamine and Neuropathic Pain (KETAPAIN)
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|ClinicalTrials.gov Identifier: NCT02467517|
Recruitment Status : Unknown
Verified July 2016 by University Hospital, Clermont-Ferrand.
Recruitment status was: Recruiting
First Posted : June 10, 2015
Last Update Posted : July 29, 2016
The primary outcome is to compare the analgesic efficacy of intravenous ketamine treatment to that of a placebo in patients with refractory neuropathic pain.
The secondary outcomes are:
- - To compare the additive analgesic efficacy of prior administration of magnesium sulfate to that of placebo and ketamine only, on the effectiveness of intravenous ketamine treatment,
- - To study the evolution time of pain and analgesia after the intravenous administration of ketamine and placebo,
- - To study the correlation of the analgesic response to administered products respectively ketamine, ketamine and magnesium sulfate, placebo.
|Condition or disease||Intervention/treatment||Phase|
|Neuropathic Pain||Drug: Ketamine Drug: Magnesium Sulfate Drug: placebo : sodium chloride||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||22 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Ketamine and Neuropathic Pain|
|Study Start Date :||November 2015|
|Estimated Primary Completion Date :||March 2018|
|Estimated Study Completion Date :||April 2018|
|Experimental: INTRAVENOUS KETAMINE||
Drug: Magnesium Sulfate
Drug: placebo : sodium chloride
- Numerical rating scale (NRS) [ Time Frame: at day 1 and for a period of 5 weeks (35 days). ]
- Intensity of the average [ Time Frame: at day 1 ]Intensity of the average daily pain evaluated by a numerical rating scale (NRS) assessed using a booklet
- Intensity of maximum daily pain [ Time Frame: at day 1 ]Intensity of maximum daily pain evaluated by a numerical rating scale (NRS) assessed using a booklet,
- Impact on quality of life [ Time Frame: at day 1 ]Impact on quality of life, mood and sleep assessed by questionnaires.
- Impact on mood [ Time Frame: at day 1 ]Impact on quality of life, mood and sleep assessed by questionnaires.
- Impact on sleep [ Time Frame: at day 1 ]Impact on quality of life, mood and sleep assessed by questionnaires.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02467517
|Contact: Patrick LACARIN||04 73 75 11 firstname.lastname@example.org|
|CHU de Clermont-Ferrand||Recruiting|
|Clermont-Ferrand, France, 63003|
|Contact: Patrick LACARIN 04 73 75 11 95 email@example.com|
|Sub-Investigator: Noémie DELAGE|
|Sub-Investigator: Pascale PICARD|
|Sub-Investigator: Fabienne MARCAILLOU|
|Sub-Investigator: Claude DUBRAY|
|Sub-Investigator: Christian DUALE|
|Principal Investigator:||Gisèle PICKERING||University Hospital, Clermont-Ferrand|