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

POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI0 个研究点开始时间: 2009年8月3日最近更新: 2012年3月19日

试验速览

暂无简介。

•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

•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.

发起方

POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI