Pain prevention during propofol infusion in pediatric: hypnoanalgesia of the hand versus lidocaine.
Phase 1
- Conditions
- surgery under general anaestheticMedDRA version: 20.0Level: PTClassification code 10054799Term: Perioperative analgesiaSystem Organ Class: 10042613 - Surgical and medical proceduresTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Registration Number
- EUCTR2017-002630-22-FR
- Lead Sponsor
- niversity Hospital of Toulouse
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
- aged 7 to 14,
- ASA I and II,
- Admitted for scheduled surgery under general anaesthetic
Are the trial subjects under 18? yes
Number of subjects for this age range: 100
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- ASA III and IV
- propofol contraindication
- lidocaine contraindication
- azote protoxyde contraindication
- psychological distress
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Evaluate the efficacity of hypnoanalgesia of the hand in order to reduce propofol-induced pain in children compared to the administration of a lidocaine-propofol admixture;Secondary Objective: The secondary objectives of the trial is to evaluate the satisfaction of patient's anaesthetic, post surgery.;Primary end point(s): The primary end point is the pain intensity evaluated by the Cameron's score.;Timepoint(s) of evaluation of this end point: 15 minutes
- Secondary Outcome Measures
Name Time Method Secondary end point(s): The secondary end point is the patient's satisfaction about anesthesia, evaluated by a modified Aldrete 3 score.;Timepoint(s) of evaluation of this end point: 8 hours