Comparison of two different routes of administration of dexmedetomidine (intranasal and nebulised ) alongwith oral ketamine as a premedication in Children 1-5 years of age undergoing elective surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- 1. Sedation score
Study Overview
Brief Summary
Premedication for children is given to relieve preoperative stress and anxiety as seen in paediatric patients undergoing any surgery.along with fear of separation from parents , this anxiety is present along with adverse outcomes via elevation of stress markers,hemodynamic instability and impacting postoperative recovery and unstable vitals.So to allay this preoperative anxiety and achieve smoother induction of anaesthesia,a variety of pharmacological and non pharmacological methods have been proposed. various medications have been used through intravenous routes, but still not acceptable due to fear of needle, so dexmedetomidine which is an alpha 2 agonist, through two different routes( intranasal and nebulised) along with oral ketamine which is a non barbiturate cyclohexanone derivative produces sedation,analgesia,amnesia and anxiolysis without respiratory depression.so we are going to compare two routes of dexmedetomidine along with oral ketamine in this study as a premedication and assess various outcomes like sedation score, parental separation anxiety scale,medication and mask acceptance scale,recovery time,FLACCscale,consolabilty scale,emergence agitation scale,wong baker scale,modified adrete scale as various studies have been conducted using intranasal dexmedetomidine and nebulised dexmedetomidine alone as well as in combination with ketamine with good analgesic and antianxiety effect,also these procedures are standard and routine and so we will make sure the comfort and safety of patient is not compromised and no financial burden is put on the patient.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Not Applicable
Eligibility Criteria
- Ages
- 1.00 Year(s) to 5.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Age 1-5 years
- •Both genders
- •ASA grade 1,2
- •Paediatric patient undergoing below umbilical surgery
- •Non-emergency surgery under general anaesthesia.
Exclusion Criteria
- •Age >5 years
- •Non assenting parents for their child
- •Known sensitivity to ketamine or dexmedetomidine,
- •Paediatric patient of ASA Grade 3,4
- •Any known congenital heart diseases, raised intracranial pressure, raised intraocular pressure or mental retardation.
Outcomes
Primary Outcomes
1. Sedation score
Time Frame: Intranasal or nebulised dexmedetomidine will be given with ketamine and time will be noted at that time and after every 10 min till 30 min | T0- time just before giving premedication and noting down vital parameters | T1- time of giving premedication | T2- time after 10 minutes of premedication and assessing sedation scale | T3- time after 20 minutes of premedication | T4- time after 30 minutes of premedication and shifting the patient to OT
2. Parental separation anxiety scale
Time Frame: Intranasal or nebulised dexmedetomidine will be given with ketamine and time will be noted at that time and after every 10 min till 30 min | T0- time just before giving premedication and noting down vital parameters | T1- time of giving premedication | T2- time after 10 minutes of premedication and assessing sedation scale | T3- time after 20 minutes of premedication | T4- time after 30 minutes of premedication and shifting the patient to OT
3. Medication and mask acceptance scale
Time Frame: Intranasal or nebulised dexmedetomidine will be given with ketamine and time will be noted at that time and after every 10 min till 30 min | T0- time just before giving premedication and noting down vital parameters | T1- time of giving premedication | T2- time after 10 minutes of premedication and assessing sedation scale | T3- time after 20 minutes of premedication | T4- time after 30 minutes of premedication and shifting the patient to OT
4. Recovery time
Time Frame: Intranasal or nebulised dexmedetomidine will be given with ketamine and time will be noted at that time and after every 10 min till 30 min | T0- time just before giving premedication and noting down vital parameters | T1- time of giving premedication | T2- time after 10 minutes of premedication and assessing sedation scale | T3- time after 20 minutes of premedication | T4- time after 30 minutes of premedication and shifting the patient to OT
5. FLACC scale
Time Frame: Intranasal or nebulised dexmedetomidine will be given with ketamine and time will be noted at that time and after every 10 min till 30 min | T0- time just before giving premedication and noting down vital parameters | T1- time of giving premedication | T2- time after 10 minutes of premedication and assessing sedation scale | T3- time after 20 minutes of premedication | T4- time after 30 minutes of premedication and shifting the patient to OT
6. Consolability scale
Time Frame: Intranasal or nebulised dexmedetomidine will be given with ketamine and time will be noted at that time and after every 10 min till 30 min | T0- time just before giving premedication and noting down vital parameters | T1- time of giving premedication | T2- time after 10 minutes of premedication and assessing sedation scale | T3- time after 20 minutes of premedication | T4- time after 30 minutes of premedication and shifting the patient to OT
7. Emergence agitation scale
Time Frame: Intranasal or nebulised dexmedetomidine will be given with ketamine and time will be noted at that time and after every 10 min till 30 min | T0- time just before giving premedication and noting down vital parameters | T1- time of giving premedication | T2- time after 10 minutes of premedication and assessing sedation scale | T3- time after 20 minutes of premedication | T4- time after 30 minutes of premedication and shifting the patient to OT
8. Wong baker scale
Time Frame: Intranasal or nebulised dexmedetomidine will be given with ketamine and time will be noted at that time and after every 10 min till 30 min | T0- time just before giving premedication and noting down vital parameters | T1- time of giving premedication | T2- time after 10 minutes of premedication and assessing sedation scale | T3- time after 20 minutes of premedication | T4- time after 30 minutes of premedication and shifting the patient to OT
9. Modified aldrete score
Time Frame: Intranasal or nebulised dexmedetomidine will be given with ketamine and time will be noted at that time and after every 10 min till 30 min | T0- time just before giving premedication and noting down vital parameters | T1- time of giving premedication | T2- time after 10 minutes of premedication and assessing sedation scale | T3- time after 20 minutes of premedication | T4- time after 30 minutes of premedication and shifting the patient to OT
Secondary Outcomes
- 1. Sedation score(2. Parental separation anxiety scale)