A randomized comparative study of intranasal atomized dexmedetomidine versus ketamine as a premedication in children undergoing adenotonsillectomy in general anaesthesia at SMS Medical College Jaipur
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- 1.To assess and compare the degree of sedation using the University of Michigan Sedation Scale (UMSS) between intranasal atomized dexmedetomidine versus ketamine.
Study Overview
Brief Summary
Paediatric patients present a unique set of challenges to the anaesthetist as preoperative anxiety in children leads to a difficulty in parental separation, i.v. cannulation, induction of anaesthesia, greater analgesic requirements and emergence agitation .Hence, the administration of balanced short-acting sedative agents with minimal risk of respiratory dysfunction is recommended under close monitoring of vitals. Dexmedetomidine is a selective alpha 2 agonist similar to clonidine, but with higher affinity to the alpha 2 receptor. It produces dose-dependent sedation, anxiolysis, and analgesia without respiratory depression and minimal effect on respiratory rate and tidal volume. Ketamine acts on the N methyl D aspartate receptor (NMDA R) producing a dissociative anesthesia. Ketamine is known to reduce central sensitization to pain, decrease overall opioid utilization, and produce effective sedation level. Oral administration has low bioavailability. Parenteral and intramuscular routes are invasive and painful. Intranasal application is a relatively non-invasive and easy route of administration which has the additional benefit of not requiring patient cooperation. With this background, we have planned this study to compare the efficacy of intranasal atomized dexmedetomidine versus ketamine as a premedication for anxiolysis and sedation in pediatric patients undergoing adenotonsillectomy in general anaesthesia.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 3.00 Year(s) to 10.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.Children scheduled for adenotonsillectomy under general anaesthesia.
- •2.Patients belonging to American Society of Anaesthesiologists (ASA) class I and II.
- •3.Patient’s parents willing to give informed written consent.
Exclusion Criteria
- •1.Patients with known allergies to dexmedetomidine or ketamine.
- •2.Patients with weight greater than 25 kg.
- •3.Patients with any congenital anomaly or syndrome.
- •4.Patients with history of seizures.
- •5.Patients with upper respiratory tract infection.
- •6.Patients with airway malformations or anticipated difficult airway.
- •7.Patients with intellectual disability.
- •8.Patients involved in any other study.
Outcomes
Primary Outcomes
1.To assess and compare the degree of sedation using the University of Michigan Sedation Scale (UMSS) between intranasal atomized dexmedetomidine versus ketamine.
Time Frame: 10 minutes, 20 minutes, 30 minutes
2.To assess and compare the ease of parental separation using Parental Separation Anxiety Score (PSAS) between the two groups
Time Frame: 10 minutes, 20 minutes, 30 minutes
Secondary Outcomes
- 1.To assess and compare mask acceptance using Mask Acceptance Score (MAS) between the two groups .(2.To assess and compare the ease of venous cannulation using Groningen Distress Rating Scale (GDRS) between the two groups.)
Investigators
Dr Mamta Sharma
Sawai Man Singh Medical College Jaipur