Intranasal dexmedetomidine to facilitate mask induction 1 and prevent emergence delirium. 2


 Background As children are exposed to stress and anxiety during the perioperative period, pre-anaesthetic medication to facilitate induction of anaesthesia without prolonging recovery is needed. Dexmedetomidine is increasingly being used for sedation in the intensive care units and for procedural anaesthesia outside the operating room. However, the effectiveness of pre-operative sedation with intranasal dexmedetomidine in paediatric patients undergoing ambulatory surgery has not yet been well characterised. Aims To identify the effectiveness of intranasal dexmedetomidine in facilitating mask induction and preventing emergence agitation. Methods In a single centre retrospective implementation study, we compared intranasal dexmedetomidine (2 µg/kg) administration, sequentially in all paediatric patients undergoing minor urological surgery between January 2019 and July 2019 with a period in which dexmedetomidine was not administered. The outcome measures were tolerance of mask induction, post-operative sedation and the Paediatric Anaesthesia Emergence Delirium scale (PAED) score. Results The 53 children in the control group were compared with 50 children in the dexmedetomidine group during implementation. The incidence of sedation on mask induction was greater in patients given dexmedetomidine compared to those who did not receive premedication (60% versus 0%, p<0.0001). The proportion of children who were asleep but easily arousable in the recovery room and in day-care hospital was greater in the dexmedetomidine group compared to the control group. (32% versus 7% in the recovery room; p=0.004, and 20% versus 2% in day-care hospital, p = 0.002). The PAED scores did not differ between the two groups, neither in the recovery room nor in day-care hospital. Conclusion In paediatric patients undergoing small urologic surgery, premedication with intranasal dexmedetomidine in a dose of 2µg/kg provides adequate sedation and anxiolysis on mask induction and in the postoperative period. These results from an implementation study need to be confirmed in a multicentre blinded randomised controlled trial.


Background 23
As children are exposed to stress and anxiety during the perioperative period, pre-anaesthetic 24 medication to facilitate induction of anaesthesia without prolonging recovery is needed. 25 Dexmedetomidine is increasingly being used for sedation in the intensive care units and for 26 procedural anaesthesia outside the operating room. However, the effectiveness of pre-operative 27 sedation with intranasal dexmedetomidine in paediatric patients undergoing ambulatory surgery 28 has not yet been well characterised. 29

Aims 30
To identify the effectiveness of intranasal dexmedetomidine in facilitating mask induction and 31 preventing emergence agitation. 32

Methods 33
In a single centre retrospective implementation study, we compared intranasal dexmedetomidine 34 (2 µg/kg) administration, sequentially in all paediatric patients undergoing minor urological 35 surgery between January 2019 and July 2019 with a period in which dexmedetomidine was not 36 administered. The outcome measures were tolerance of mask induction, post-operative sedation 37 and the Paediatric Anaesthesia Emergence Delirium scale (PAED) score. 38

Results 39
The 53 children in the control group were compared with 50 children in the dexmedetomidine 40 group during implementation. The incidence of sedation on mask induction was greater in patients 41 given dexmedetomidine compared to those who did not receive premedication (60% versus 0%, 42 p<0.0001). The proportion of children who were asleep but easily arousable in the recovery room 43 and in day-care hospital was greater in the dexmedetomidine group compared to the control group. 44 (32% versus 7% in the recovery room; p=0.004, and 20% versus 2% in day-care hospital, p = 45 3 0.002). The PAED scores did not differ between the two groups, neither in the recovery room nor 46 in day-care hospital. 47

Conclusion 48
In paediatric patients undergoing small urologic surgery, premedication with intranasal 49 dexmedetomidine in a dose of 2µg/kg provides adequate sedation and anxiolysis on mask 50 induction and in the postoperative period. These results from an implementation study need to be 51 confirmed in a multicentre blinded randomised controlled trial. Children undergoing surgical procedures can experience significant stress, anxiety and distress 68 during the perioperative period, which may be due to separation from parents, fear of injections 69 or fear of the operating theatre. This may lead to agitation or excess crying, which also make the  Dexmedetomidine is a newer and potent, highly selective and specific alpha-2 adrenoceptor 87 agonist with sedative, anxiolytic, sympatholytic and analgesic effects. resistance, 2 = moderate resistance, 3 = strong resistance) to assess the degree of mask acceptance. 126 The assessments were done by the attending anaesthetist. 127 In the recovery room, patients were monitored for non-invasive blood pressure, heart rate and 128 pulse oxygen saturation. Children were continuously assessed for agitation by nursing staff and 129 maximal PAED scores were recorded. The patients were discharged when the modified Aldrete 130 score was > 9. In day-care hospital PAED scores were also registered. Any adverse event 131 including bradycardia, hypotension, nausea of vomiting and respiratory depression was recorded 132 during the entire hospital stay.

General characteristics 142
A total of 103 ASA I patients undergoing small urologic procedures were included in this study. 143 Fifty patients received preoperative dexmedetomidine intranasally and 53 did not being defined 144 as the control group. The weight and age of all patients did not differ between both groups. The 145 administered dose of dexmedetomidine in the treatment group was mean 2.01 ± 0.08 mg/kg 146 Arrival in the operation theatre and mask acceptance 147 All patients in the control group were fully awake upon arrival in the operation theatre. In 148 comparison, 46% of the patients in the dexmedetomidine group were slightly sedated and 12% 149 were deeply sedated (p<0.001). (Table 1) However, mask acceptance did not differ between the 150 dexmedetomidine and control group (p=0.17). (Table 2   The scale of sedation was compared between both groups and was expressed as 1 (awake), 2 (slightly sedated) or 3 156 (deeply sedated/anaesthesia).

Postoperative emergence agitation 161
Only 7% of the patients in the control group were asleep but easily arousable in the recovery 162 room, in contrast to the 32% in the dexmedetomidine group (p = 0.004). (Table 3) In day-care 163 hospital, more patients were asleep in the dexmedetomidine group in comparison to the control 164 group (10/50 (20%) and 1/53 (2%) respectively. p = 0.002). (Table 4) However, the Paediatric 165 Anaesthesia Emergence Delirium scale (PAED) scores did not differ between the two groups, 166 neither in the recovery room nor in day-care hospital. ( figure 1 and figure 2). 167   Ethics approval and consent to participate 232 All methods were carried out in accordance with relevant guidelines and regulations. All 233 experimental protocols were approved by the institutional board of Ziekenhuis Oost-Limburg. 234 Informed Consent was waived by institutional board and ethical committee of Ziekenhuis Oost-235 Limburg due to retrospective nature of the study. 236

Consent for publication 237
Not applicable 238

Availability of data and materials 239
The datasets used and/or analysed during the current study are available from the corresponding 240 author on reasonable request. 241

Competing interests 242
The authors certify that they have no affiliations with or involvement in any organization or entity 243 with any financial interest in the subject matter or materials discussed in this study. 244