Health Condition 1: J958- Other intraoperative and postprocedural complications and disorders of respiratory system, not elsewhere classified
Conditions
Interventions
Intervention1: IV Ketamine and Midazolam: Midazolam 0.1mg per kg diluted as 1mg per ml administered over 30 seconds at 0.1ml per kg.
Study drug Ketamine 1 mg per kg diluted as 10 mg per ml administer
Sponsors
All India Institute of Medical Sciences
Eligibility
Inclusion criteria
Inclusion criteria: Children of age 6 months to 5 years undergoing flexible bronchoscopy
Exclusion criteria
Exclusion criteria: Cardiovascular instability requiring inotropic support. Any known allergy to the sedation agents. Raised intracranial pressure Hepatic dysfunction - AST and ALT more than 3times the Upper limit - prolonged PT and or INR - total bilirubin more than 3mg per dL. Children with altered consciousness before the procedure. Already receiving any form of sedation before the procedure. Children on ventilatory support- invasive or non-invasive
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate efficacy of sedation by ketamine-midazolam compared to fentanyl-midazolam in children undergoing flexible bronchoscopy of age group 6 months to 5 years of ageTimepoint: Baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Requirement of additional adjuvant midazolam Timepoint: During procedure;Failure to achieve sedationTimepoint: during procedure;Bronchoscopist satisfaction for doing the bronchoscopyTimepoint: After the procedure;Time to achieve conscious sedationTimepoint: Time from intervention to adequate sedation;Recovery time to full consciousness after the procedureTimepoint: After the procedure;Adverse effectsTimepoint: During and after the procedure | — |
Countries
India
Contacts
Public ContactKana Ram Jat
All India Institute of Medical Sciences
Outcome results
None listed