Comparative study between two routes of Midazolam administeration for sedation in children.
Phase 2
- Conditions
- Health Condition 1: O- Medical and SurgicalHealth Condition 2: O- Medical and Surgical
- Registration Number
- CTRI/2024/07/071230
- Lead Sponsor
- Dr Reem Khatib
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1-5 years aged patients of either sex
ASA I – II
Patients posted for routine paediatric surgeries
Hemodynamically stable patients with all routine investigations within normal limits.
Patients whose parents or guardians give written informed consent and are willing their child to be a part of the study.
Exclusion Criteria
6 years and above
ASA grade 3 and above
known allergy to study drugs
nasal pathology
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the effectiveness of preoperative Oral Midazolam with Intranasal Midazolam for sedative premedication in paediatric patients.Timepoint: Five point sedation score followed by parental separation score will be assessed at the end of 20 minutes from administeration of the drug.
- Secondary Outcome Measures
Name Time Method To compare the effectiveness of preoperative Oral Midazolam with Intranasal Midazolam for sedative premedication in paediatric patients.Timepoint: Acceptance to mask & response to venepuncture will be assessed after 20 minutes of drug administer in the operating room <br/ ><br>The Modified Alderte score shall be assessed for 30 minutes from extubation in the recovery room