Condition category
Signs and Symptoms
Date applied
28/11/2009
Date assigned
19/02/2010
Last edited
12/04/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.chu-angers.fr/

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

Publication citations

Additional files

Editorial Notes