Status:
COMPLETED
Pain Prevention During Propofol Infusion in Pediatric: Hypnoanalgesia of the Hand Versus Lidocaine.
Lead Sponsor:
University Hospital, Toulouse
Conditions:
Pain
Eligibility:
All Genders
7-14 years
Phase:
PHASE4
Brief Summary
The simplicity of the implementation and the effectiveness of hypno-analgesia (via the magic glove technique) has already been proven in some research work, during the installation of peripheral venou...
Detailed Description
Propofol is a hypnotic of choice, because of its speed of action, its dose-effect relationship (allowing titrated inductions), its anti-emetic effect, as well as its delay and its short duration of ac...
Eligibility Criteria
Inclusion
- Children from 7 to 14 years old.
- Admitted for programmed or ambulatory surgery under general anesthesia.
- ASA I to II. (ASA1: Normal patient or ASA 2: Patient with moderate systemic abnormality).
- Parents or legal guardians who have signed informed consent to the inclusion visit.
Exclusion
- Children under 7, over 14
- In regulated girls, presence of a pregnancy
- ASA III, IV
- Contraindication to propofol (known hypersensitivity to propofol or to one of its constituents)
- Contraindications to lidocaine (known hypersensitivity to lidocaine hydrochloride, amide bonded local anesthetics or to any of the excipients, patients with recurrent porphyria)
- Contraindications to nitrous oxide
- Patient whose clinical condition requires titration of propofol during induction, for good hemodynamic tolerance.
- Refusal by the child or the parents of intravenous induction.
- Psychological distress (agitation, mental deficiencies, communication disorders, deafness problems).
- Analgesic or sedative treatment within 24 hours before induction.
- Locoregional or perimedullary anesthesia before anesthetic induction.
Key Trial Info
Start Date :
April 18 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 19 2019
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03453723
Start Date
April 18 2018
End Date
June 19 2019
Last Update
November 28 2025
Active Locations (1)
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1
Hôpital des enfants - Pôle Anesthésie-Réanimation.
Toulouse, France, 31059