intra-nasal premedication instead of oral, intravenous or no premedication. MedDRA version: 20.0 Level: PT Classification code 10042609 Term: Surgery System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Trade Name: CATAPRESSAN solution injectable Clonidine
Pharmaceutical Form: Concentrate and solvent for solution for injection
Pharmaceutical form of the placebo: Concentrate for solution for injection
Sponsors
CHRU LILLE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age of 1 to 5 years, - Weight from 10 to 25 kg - Signature of informed consent - ASA 1 or 2, (ANNEX 6) - Scheduled minor surgery - Affiliation to Social Security Are the trial subjects under 18? yes Number of subjects for this age range: 150 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
Exclusion criteria: - Failure to obtain consent, - Participation in another clinical trial involving a drug, - Known contraindications or hypersensitivity to clonidine, or to any of the excipients, - Upper airway infection within 3 weeks prior to inclusion, - Intravenous Induction, - History of cardiac arrhythmia, congenital heart disease, - Mental retardation or psychoactive treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of this study is to evaluate the efficacy of intranasal clonidine vs placebo in premedication in pediatric surgery on anxiolytic separation with parents.;Secondary Objective: The secondary objectives of this study are to evaluate the efficacy of intranasal clonidine on anxiolysis at induction and on awakening, as well as the undesirable effects of premonication with clonidine.;Primary end point(s): The primary endpoint is: The anxiolytic score at 30 min after administration of premedication ie at the time of separation with the parents. The anxiolyse will be defined by a score greater than or equal to 3.;Timepoint(s) of evaluation of this end point: 30 min after administration of premedication ie at the time of separation with the parents | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary evaluation criteria are: - the acceptance of the mask at the induction of anesthesia, The postoperative agitation measured by the anxiolytic score 15 min after extubation and at the exit of SSPI, - the presence of adverse effects on the respiratory rate, defined by a value lower than the norm - the presence of a desaturation defined by an SpO2 value of less than or equal to 94% for more than 30 seconds - the presence of undesirable effects on the heart rate, defined by a value higher or lower than the norm - the tolerance of intranasal administration. Intolerance of administration will be defined by crying of the child, a burning sensation or a bitter taste to the administration of the product. - the existence of postoperative behavior disorders on D1 and D7, defined by a score PHBQ> 68. - an increase in the time between the withdrawal of sevoflurane and extubation - the need to administer morphine in the recovery room - the need for analgesics other than paracetamol in postoperative care;Timepoint(s) of evaluation of this end point: At the induction of the anesthesia, 15 min after extubation and at the exit of SSPI, J1 and at J7 post-operative. | — |
Countries
France
Contacts
Public ContactAbdeljalil AKCHICH
chru de lille
Outcome results
None listed