Comparison of Ease of Administration of nasal Midazolam Spray and Midazolam Syrup by Parents to Children before Surgery
Not Applicable
- Conditions
- Health Condition 1: null- Children of age 1 to 6 yrs of ASA physical status 1 and 2 undergoing elective surgical procedures
- Registration Number
- CTRI/2015/01/005449
- Lead Sponsor
- JIPMER
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 90
Inclusion Criteria
Undergoing Elective surgeries
ASA physical status I and II
Exclusion Criteria
CNS disorders like epilepsy, pathology with raised ICT, developmental delay, mental retardation.
Prolonged therapy with hepatic enzyme inducing drugs
Respiratory system dysfunction (rhinorrhea, bronchial asthma, nasal polyps)
Cardiac and renal abnormalities
Nasal pathology and nasal infections
Children with difficult airway and obstructive sleep apnea syndrome
Parents who have preference of drug administration via oral or intranasal route
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the ease of administration of intranasal midazolam spray and oral midazolam syrup by parentsTimepoint: 1.5 yrs
- Secondary Outcome Measures
Name Time Method To compare the preoperative separation anxiolysis and sedation of intranasal midazolam and oral midazolam administered by parentsTimepoint: 1.5 years