Comparison of intranasal dexmedetomidine and dexmedetomidine-ketamine for premedication in pediatrics patients: A randomized double-blind study

Abstract

Background:Goal of premedication in pediatric anesthesia are relieving pre and postoperative anxiety, good parental separation, and smooth induction of anesthesia. Anxiety can produce aggressive reactions, increased distress, increased postoperative pain and postoperative agitation. The benzodiazepine, midazolam, is the most frequently used premedication in pediatric anesthesia. Midazolam has a number of beneficial effects when used as premedication in children: Sedation, fast onset, and limited duration of action. Though midazolam has a number of beneficial effects, it is far from an ideal premedicant having untoward side effects such as paradoxical reaction, respiratory depression, cognitive impairment, amnesia, and restlessness. Dexmedetomidine is a newer α-2-agonist, which can be used as premedicant.Aims:To compare the level of sedation, parental separation, mask acceptance, postoperative recovery of intranasal premedication with dexmedetomidine and dexmedetomidine-ketamine combination in pediatric patients.Settings and Design:Prospective randomized double-blind study.Subjects and Methods:After written informed consent from the patient's parents or legal guardian, 54 children of American Society of Anesthesiologists physical status I or II, aged between 1 and 6 years, scheduled to undergo elective minor surgery were enrolled. In group D patient received 1 μg/kg dexmedetomidine intranasally and in group DK received 1 μg/kg dexmedetomidine and 2 mg/kg ketamine intranasally. Patients were assessed every 10 min for the level of sedation, parenteral separation, heart rate, and oxygen saturation by an independent observer. Mask acceptance and postoperative agitation were noted using an appropriate scale.Statistical Analysis Used:Pearson Chi-square analysis to determine differences between two groups with respect to separation anxiety and acceptance of the anesthesia mask. Percentages used to represent frequencies. The level of significance was set at P< 0.05.Results:Acceptable parenteral separation was achieved in 90% of patients 30 min after premedication. Sedation was acceptable in 80% of patients at induction. Good mask acceptance was seen in 60% of patients. The incidence of emergence agitation (EA) was 2%. None of the above parameters was statistically significant between the two groups.Conclusions:Dexmedetomidine, as premedicant in children provides acceptable parenteral separation. However, mask acceptance in operation room is poor. Combination of dexmedetomidine and ketamine does not increase the success of premedication. Use of dexmedetomidine is associated with decreased EA.

Comparison of nebulised dexmedetomidine, ketamine, or midazolam for premedication in preschool children undergoing bone marrow biopsy

“…i.v., oral, buccal, rectal, and intranasal), with each route having its own advantages and disadvantages. 7 The inhalation route used in this study may offer an alternative mode of administration of sedative premedication that is relatively easy to set up, and does not require an i.v. cannulation or injection, but is still associated with high bioavailability of the administered drug.…”

“…5,6 Ketamine is an N-methyl-d-aspartate (NMDA) receptor antagonist that produces a state of sedation, anaesthesia, immobility, analgesia, and amnesia. 7,8 Sedative premedication in children is commonly administered via the oral, rectal, sublingual, and intranasal routes with varying degrees of patient acceptance. 1e8 Inhalation of nebulised drug is an alternative method of administration that is relatively easy to set up, does not require venepuncture, and is associated with high bioavailability of the administered drug.…”

Dexmedetomidine for refractory adrenergic crisis in familial dysautonomia

“…In this regard, the potential role of intranasal dexmedetomidine for FD patients is appealing. Intranasal dexmedetomidine has been used to pre-medicate pediatric patients undergoing diagnostic and therapeutic procedures to provide light sedation and blunt sympathetic activity [2, 8, 15, 18, 28]. Because initial management of FD crises typically occurs at home, the availability of a medication with rapid onset, effectiveness via the intranasal route, and minimal risk of respiratory depression, would pose a significant therapeutic innovation.…”

The intranasal dexmedetomidine plus ketamine for procedural sedation in children, adaptive randomized controlled non-inferiority multicenter trial (Ketodex): a statistical analysis plan

“…We assume a binomial likelihood for the data and a beta prior with parameters 6.25 and 0.25 for each dose. This prior is informed by previous data [ 21 ] and then down-weighted by 4 to an effective sample size of 6.5 [ 22 ]. Using the same prior for all three doses assumes they have the same effectiveness unless the data indicate otherwise.…”

“…We will use non-central t distributions with precision 0.001 and degrees of freedom 1, suggested by [ 25 ]. The mean of β 1 and β a assume that 5% of participants are under-sedated and 2% over-sedated, setting the prior means for to 0.93, the effectiveness from the literature [ 21 ]. The priors for β 2 , β 3 , β b and β c are centered on 0 so all dose combinations initially have the same effectiveness.…”