Skip to main content
MedPathMedPath Home
Clinical Trials/EUCTR2016-002890-37-ES
EUCTR2016-002890-37-ES
Active, not recruiting
Phase 1

Double-blind randomized clinical trial to compare presurgery anxiolysis in children treated with hydroxyzine versus non-pharmacological intervention (distractoria technique clown). - SMILE

Esther Aleo Lujan0 sites188 target enrollmentAugust 5, 2016
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
DrugsAtarax

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
Esther Aleo Lujan
Enrollment
188
Status
Active, not recruiting
Last Updated
5 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 5, 2016
End Date
TBD
Last Updated
5 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Esther Aleo Lujan

Eligibility Criteria

Inclusion Criteria

  • •\- 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.
  • •Are the trial subjects under 18? yes
  • •Number of subjects for this age range: 188
  • •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

Exclusion Criteria

  • •\- 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, 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.
  • •\- Pregnancy and lactation.

Outcomes

Primary Outcomes

Not specified

Similar Trials

Active, not recruiting
Not Applicable
Clinical study to compare two creams with the active substances fusidic acid and betamethasone and one cream without active substance for patients with bacterial infected eczemas.Bacterial infected eczemasMedDRA version: 17.1Level: PTClassification code 10014199Term: Eczema infectedSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
EUCTR2011-004370-28-DEDermapharm AG
Completed
Not Applicable
Comparing the effect of polyethylene glycol and C-lax in bowel preparation for colonoscopyBowel functional disorders.Other specified diseases of digestive system
IRCT201601161264N7Golestan University of Medical Sciences300
Recruiting
Not Applicable
Assessment pityriasis versicolor´s treatmenmt comparing Ketoconazol 2 % cream with Benzoyl Peroxide cream 5% isolateds and with these two together in cream
RBR-3jtxjsniversidade Federal de Pernambuco
Active, not recruiting
Not Applicable
Double-blind, randomized, clinical trial to compare the efficacy and safety of diclofenc 3% gel vs. Solaraze 3% gel vs. vehicle for the treatment of patients with actinic keratosis.
EUCTR2011-003317-41-DEDermapharm AG
Recruiting
Not Applicable
A study to compare effects of two drugs dexmeditomidine and fentanyl on blood pressure, pulse and recovery from general anesthesia in patients undergoing Ear Nose or throat surgery.Health Condition 1: null- ASA Class 1&2 patients scheduled for elective ENT surgeries.
CTRI/2015/07/006053Dr Rohit Kaushikbhai Patel60