Comparison of two different routes of administration of dexmedetomidine with oral ketamine to relieve anxiety before operation in young children

Not yet recruiting

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2021/11/038091
• Lead Sponsor: Adesh institute of Medical sciences ResearchBathinda

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.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2021-11-16
• Study Start: 2021-11-20

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Age 1-5 years 2.
• Both genders 3.
• ASA grade 1,2 4.
• Paediatric patient undergoing below umbilical surgery 5.
• Non-emergency surgery under general anaesthesia.

Exclusion Criteria

• Age >5 years 2.
• Non assenting parents for their child 3.
• Known sensitivity to ketamine or dexmedetomidine, 4.
• Paediatric patient of ASA Grade 3,4 5.
• Any known congenital heart diseases, raised intracranial pressure, raised intraocular pressure or mental retardation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Sedation score	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	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	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	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	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	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	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	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	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 Outcome Measures

Name	Time	Method
1. Sedation score	2. Parental separation anxiety scale

Trial Locations

Locations (1)

Adesh institute of Medical sciences & Research,Bathinda; 🇮🇳 Bathinda, PUNJAB, India

Adesh institute of Medical sciences & Research,Bathinda

🇮🇳Bathinda, PUNJAB, India

Dr Priyanka Rana

Principal investigator

7009703862

priyankanesthesia@gmail.com