Health Condition 1: H90- Conductive and sensorineural hearing loss Health Condition 2: F80- Specific developmental disorders of speech and language
Conditions
Interventions
Intervention1: Syrup Melatonin
: 0.5mg/kg oral
If sedation is not achieved in 30 minutes, half of the 1st dose will be repeated upto maximum dos of 20mg.
Intervention2: Placebo: The placebo formulatio
Sponsors
Christian Medical College Vellore
Eligibility
Inclusion criteria
Inclusion criteria: All consecutive children aged 6 months to 6 years, scheduled for Auditory Brainstem Response Audiometry
Exclusion criteria
Exclusion criteria: 1 Refusal to take part in the study 2 Hypersensitivity to Melatonin or Triclofos 3 Obesity with BMI more than or equal to 30 4 ASA grade more than 2
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary objective of the study is to evaluate 1. Efficacy in terms of a) Successful completion of the procedure b) level of consciousness (sleep and movement) 2. Safety in terms of a) Heart rate b) Respiratory rate c) Oxygen saturation 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
| Measure | Time frame |
|---|---|
| Secondary outcome is to measure the 1. time of parental separation 2. time taken for onset of sedation 3. post recovery behavior 4. number of attempts Timepoint: End point is recovery of patient to pre-drug administration levels | — |
Countries
India
Contacts
Public ContactDr Trupthi M C
Christian Medical College, Vellore
Outcome results
None listed