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ISRCTN
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ISRCTN61356305
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ClinicalTrials.gov identifier
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Public title
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Effect of Premedication on Pain Perception: functional Magnetic Resonance Imaging (fMRI) study of healthy volunteers
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Scientific title
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A double blind randomised prospective study on the effect of premedication on pain perception: functional magnetic resonance imaging (fMRI) study of healthy volunteers
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Acronym
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PPPMRI
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Serial number at source
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2008-006826-33
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Study hypothesis
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Premedication reduces pain-related cerebral activation.
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Lay summary
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Ethics approval
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Local medical ethics committee (Comité de protection des personnes Ouest II) approved on the 13th March 2009 (ref: 2008-36)
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Study design
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Double blind randomised prospective study
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Countries of recruitment
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France
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Disease/condition/study domain
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Pain perception
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Participants - inclusion criteria
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1. Informed consent
2. Right handed
3. American Society of Anaesthesiology (ASA) classification I or II
4. No chronic drug therapy
5. No MRI contraindication
6. Accept the interdiction to drive car and drink alcohol until next morning
7. Aged 25 - 65 years, either sex
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Participants - exclusion criteria
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1. Myasthenia
2. Hypersensibility to midazolam and hydroxyzine
3. MRI contraindication
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Anticipated start date
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01/12/2009
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Anticipated end date
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01/12/2010
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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17
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Interventions
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Placebo, hydoxyzine or midazolam ingestion one hour before sequential electrical right forearm pain stimulation and fMRI examination.
The interventions consist of a unique dose ingestion of placebo, hydroxyzine (0.9 mg/kg), and midazolam (0.1 mg/kg) in orange juice, in a randomised design with one week between each session. The follow-up is 6 hours in each arm.
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Primary outcome measure(s)
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Volume of central pain matrix activation on fMRI, obtained by contrasting painful stimulation period with resting state period during fMRI recording.
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Secondary outcome measure(s)
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Visual analogic pain score, measured at the end of each 6 seconds painful stimulation period.
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Sources of funding
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University Hospital Centre of Angers (Centre Hospitalier Universitaire d'Angers) (France)
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Trial website
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Publications
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Contact name
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Dr
Ter Minassian
Aram
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Address
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CHU Angers réanimation chirurgicale B
Hôpital Larrey
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City/town
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Angers
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Zip/Postcode
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49993 CEDEX 9
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Country
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France
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Tel
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+33 (0)2 41 35 39 51
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Fax
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+33 (0)2 41 35 52 24
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Email
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arterminassian@chu-angers.fr
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Sponsor
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University Hospital Centre of Angers (Centre Hospitalier Universitaire d'Angers) (France)
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Address
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Direction des affaires médicales et de la recherche
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City/town
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Angers
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Zip/Postcode
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49993 CEDEX 9
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Country
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France
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Tel
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+33 (0)2 41 35 32 85
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Fax
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+33 (0)2 41 35 32 89
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Email
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DAM@chu-angers.fr
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Sponsor website:
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http://www.chu-angers.fr/
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Date applied
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28/11/2009
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Last edited
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12/04/2011
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Date ISRCTN assigned
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19/02/2010
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