Status:
TERMINATED
Presurgery Anxiolysis in Children Treated With Hydroxyzine Versus Non-pharmacological Intervention (Distractoria Technique Clown)
Lead Sponsor:
Hospital San Carlos, Madrid
Conditions:
Anxiety
Eligibility:
All Genders
2-16 years
Phase:
PHASE4
Brief Summary
This study evaluate the change in preoperative anxiety, baseline (M1) and pre-induction anxiety levels (M3), as shown by children undergoing MAS determined by the m-YPAS scale in the different APO man...
Eligibility Criteria
Inclusion
- Children between 2 and 16 years old
- Patients with programmed major ambulatory surgery.
- Assessment of anesthetic risk ASA I-II.
- Informed consent signed by their legal authorized representatives.
- No antihistaminic allergies.
- Assent signed by children between 12 and 16 years old.
Exclusion
- Patients with previous surgeries.
- Anesthetic risk ASA more than II.
- Patients with hypersensitivity to the active substance, to any of the excipients, to cetirizine, to other piperazine derivatives, to aminophylline or etilenamida
- Patients with porphyria
- Patients with known QT prolongation, either congenital or acquired
- Patients with known risk factors for QT prolongation including a pre-existing cardiovascular disease, previous electrolyte imbalances, family history of sudden cardiac death, significant bradycardia and concomitant use of drugs with potential known to produce QT prolongation and / or induce Torsades de Pointes.
Key Trial Info
Start Date :
November 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 29 2020
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT03324828
Start Date
November 1 2017
End Date
May 29 2020
Last Update
August 11 2020
Active Locations (1)
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1
Hospital Clinico San Carlos
Madrid, Spain, 28040