To compare the effectiveness and safety of two drugs to cause sedation among children for a diagnostic procedure
Phase 4
Completed
- Conditions
- Health Condition 1: null- Hearing impairment or speech delay among those children from 1 to 6 years of age who are referred for Auditory Brainstem evoked Response audiometry
- Registration Number
- CTRI/2014/10/005115
- Lead Sponsor
- Institutional review board
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 82
Inclusion Criteria
All children from 1 to 6 years of age, irrespective of developmental maturity who are referred for Auditory Brainstem evoked Response audiometry
Exclusion Criteria
1.Refusal for the procedure
2.Hypersensitivity to Midazolam
3.Nasal allergy
4.Obesity with a body mass index more than or equal to 30
5.ASA grade more than 2
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Safety <br/ ><br>2.EfficacyTimepoint: At every 5 minutes interval since onset of sedation to complete recovery <br/ ><br>
- Secondary Outcome Measures
Name Time Method â?¢Time for parental separation <br/ ><br>â?¢Nature of parental separation <br/ ><br>â?¢Time taken for onset of sedation <br/ ><br>â?¢Duration of procedure <br/ ><br>â?¢Time taken for recovery <br/ ><br>â?¢Post recovery behavior <br/ ><br>â?¢Acceptance by parents <br/ ><br>â?¢Audiologists satisfaction <br/ ><br>â?¢Number of attempts <br/ ><br>Timepoint: At every 15 minutes interval presedation and 5 minutes postsedation