Phase II trial with intranasal Midazolam delivered using a MAD (Mucosal Atomizer Device) for paediatric painful procedures. - ND

• Conditions: painful procedures in paediatric oncology; MedDRA version: 9.1Level: PTClassification code 10064882; MedDRA version: 9.1Level: LLTClassification code 10049124

• Registration Number: EUCTR2009-013107-56-IT
• Lead Sponsor: POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08-03
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Age > 1 month and < 10 years old; Procedural sedation in children (venipuncture, arterial venous collection, intramuscular injection) and/or radiographic studies (MRI, CT); Very scared child according to the OSBD scale with clinical history of anxiety and emotional trauma due to repeated unsuccessful procedures; In-out patients of both genders; Written consent form will be provided by parents or legal guardian.
Are the trial subjects under 18? yes
Number of subjects for this age range:
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

Children aged more than 10 years old; Patients with allergic and acute rhinitis, hypersensitivity to Benzodiazepine; ASA 4 children; Severe epatic failure graded according to common toxicity criteria NCI version 2; Medical history of alcoholism, drug abuse; Patients with no informed consent.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the feasibility.;Secondary Objective: To determine the tolerability and compliance of intranasal Midazolam delivered using a MAD.;Primary end point(s): Wong-Baker scale Ramsay scale