To compare syrup Melatonin with syrup Triclofos for putting children to sleep while undergoing undergoing Auditory Brainstem Evoked Response Audiometry
Phase 4
Completed
- Conditions
- Health Condition 1: H90- Conductive and sensorineural hearing lossHealth Condition 2: F80- Specific developmental disorders of speech and language
- Registration Number
- CTRI/2020/12/029616
- Lead Sponsor
- Christian Medical College Vellore
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 80
Inclusion Criteria
All consecutive children aged 6 months to 6 years, scheduled for Auditory Brainstem Response Audiometry
Exclusion Criteria
1Refusal to take part in the study
2Hypersensitivity to Melatonin or Triclofos
3Obesity with BMI more than or equal to 30
4ASA grade more than 2
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary objective of the study is to evaluate <br/ ><br>1.Efficacy in terms of <br/ ><br>a)Successful completion of the procedure <br/ ><br>b)level of consciousness (sleep and movement) <br/ ><br>2.Safety in terms of <br/ ><br>a)Heart rate <br/ ><br>b)Respiratory rate <br/ ><br>c)Oxygen saturation <br/ ><br>Timepoint: After administration of the drug each child will be monitored every 15 mins till onset of sedation and every 5 mins till recovery. End point of this study is attainment of vital signs and behaviour status to pre-drug administration level
- Secondary Outcome Measures
Name Time Method Secondary outcome is to measure the <br/ ><br>1.time of parental separation <br/ ><br>2.time taken for onset of sedation <br/ ><br>3.post recovery behavior <br/ ><br>4.number of attempts <br/ ><br>Timepoint: End point is recovery of patient to pre-drug administration levels