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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2009-013107-56-IT
Enrollment
Unknown
Registered
2009-08-03
Start date
2009-09-21
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

painful procedures in paediatric oncology MedDRA version: 9.1 Level: PT Classification code 10064882 MedDRA version: 9.1 Level: LLT Classification code 10049124

Interventions

Pharmaceutical Form: Solution for infusion INN or Proposed INN: Midazolam Concentration unit: mg/kg milligram(s)/kilogram Concentration type: equal Concentration number: .5-

Sponsors

POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Age > 1 month and =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
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—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026