Contact information
Type
Scientific
Primary contact
Dr Ter Minassian Aram
ORCID ID
Contact details
CHU Angers réanimation chirurgicale B
Hôpital Larrey
Angers
49993 CEDEX 9
France
+33 (0)2 41 35 39 51
arterminassian@chu-angers.fr
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2008-006826-33
Study information
Scientific title
A double blind randomised prospective study on the effect of premedication on pain perception: functional magnetic resonance imaging (fMRI) study of healthy volunteers
Acronym
PPPMRI
Study hypothesis
Premedication reduces pain-related cerebral activation.
Ethics approval
Local medical ethics committee (Comité de protection des personnes Ouest II) approved on the 13th March 2009 (ref: 2008-36)
Study design
Double blind randomised prospective study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Pain perception
Intervention
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.
Intervention type
Drug
Phase
Not Applicable
Drug names
Hydoxyzine, midazolam
Primary outcome measures
Volume of central pain matrix activation on fMRI, obtained by contrasting painful stimulation period with resting state period during fMRI recording.
Secondary outcome measures
Visual analogic pain score, measured at the end of each 6 seconds painful stimulation period.
Overall trial start date
01/12/2009
Overall trial end date
01/12/2010
Reason abandoned
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
17
Participant exclusion criteria
1. Myasthenia
2. Hypersensibility to midazolam and hydroxyzine
3. MRI contraindication
Recruitment start date
01/12/2009
Recruitment end date
01/12/2010
Locations
Countries of recruitment
France
Trial participating centre
CHU Angers réanimation chirurgicale B
Angers
49993 CEDEX 9
France
Sponsor information
Organisation
University Hospital Centre of Angers (Centre Hospitalier Universitaire d'Angers) (France)
Sponsor details
Direction des affaires médicales et de la recherche
Angers
49993 CEDEX 9
France
+33 (0)2 41 35 32 85
DAM@chu-angers.fr
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
University Hospital Centre of Angers (Centre Hospitalier Universitaire d'Angers) (France)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary