Effect of Premedication on Pain Perception: functional Magnetic Resonance Imaging (fMRI) study of healthy volunteers
| ISRCTN | ISRCTN61356305 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN61356305 |
| Protocol serial number | 2008-006826-33 |
| Sponsor | University Hospital Centre of Angers (Centre Hospitalier Universitaire d'Angers) (France) |
| Funder | University Hospital Centre of Angers (Centre Hospitalier Universitaire d'Angers) (France) |
- 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
Scientific
CHU Angers réanimation chirurgicale B
Hôpital Larrey
Angers
49993 CEDEX 9
France
| Phone | +33 (0)2 41 35 39 51 |
|---|---|
| arterminassian@chu-angers.fr |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Double blind randomised prospective study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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 |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Hydoxyzine, midazolam |
| Primary outcome measure(s) |
Volume of central pain matrix activation on fMRI, obtained by contrasting painful stimulation period with resting state period during fMRI recording. |
| Key secondary outcome measure(s) |
Visual analogic pain score, measured at the end of each 6 seconds painful stimulation period. |
| Completion date | 01/12/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 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
49993 CEDEX 9
France
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
