Effect of Premedication on Pain Perception: functional Magnetic Resonance Imaging (fMRI) study of healthy volunteers

ISRCTN	ISRCTN61356305
DOI	https://doi.org/10.1186/ISRCTN61356305
Secondary identifying numbers	2008-006826-33

Submission date: 28/11/2009
Registration date: 19/02/2010
Last edited: 12/04/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Signs and Symptoms

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Ter Minassian Aram
Scientific

CHU Angers réanimation chirurgicale B
Hôpital Larrey
Angers
49993 CEDEX 9
France

Phone	+33 (0)2 41 35 39 51
Email	arterminassian@chu-angers.fr

Study information

Study design	Double blind randomised prospective study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Diagnostic
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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
Study acronym	PPPMRI
Study objectives	Premedication reduces pain-related cerebral activation.
Ethics approval(s)	Local medical ethics committee (Comité de protection des personnes Ouest II) approved on the 13th March 2009 (ref: 2008-36)
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Hydoxyzine, midazolam
Primary outcome measure	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 study start date	01/12/2009
Completion date	01/12/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	17
Key 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
Key exclusion criteria	1. Myasthenia 2. Hypersensibility to midazolam and hydroxyzine 3. MRI contraindication
Date of first enrolment	01/12/2009
Date of final enrolment	01/12/2010

Locations

Countries of recruitment

France

Study participating centre

CHU Angers réanimation chirurgicale B

Angers
49993 CEDEX 9
France

Sponsor information

University Hospital Centre of Angers (Centre Hospitalier Universitaire d'Angers) (France)
Hospital/treatment centre

Direction des affaires médicales et de la recherche
Angers
49993 CEDEX 9
France

Phone	+33 (0)2 41 35 32 85
Email	DAM@chu-angers.fr
Website	http://www.chu-angers.fr/
"ROR"	https://ror.org/0250ngj72

Funders

Funder type

Hospital/treatment centre

University Hospital Centre of Angers (Centre Hospitalier Universitaire d'Angers) (France)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan