Comparison of analgesic efficacy and safety of caudal dexmedetomidine versus intranasal dexmedetomidine in paediatric infraumbilical surgeries: A randomised controlled trial.

BACKGROUND

The established analgesic efficacy and safety of dexmedetomidine in children has demonstrated a rise in its use and various administration routes have been explored. However, clinical comparisons between caudal and intranasal dexmedetomidine are lacking.

OBJECTIVES

We aimed to compare the analgesic efficacy, postanaesthesia recovery characteristics and side effects associated with caudal versus intranasal dexmedetomidine as an adjunct to a single-shot caudal block in paediatric infraumbilical surgeries.

DESIGN

A noninferiority randomised controlled trial.

SETTING

A tertiary care hospital from November 2022 to May 2024.

PATIENTS

Sixty-four children aged 1 to 8 years undergoing infraumbilical surgeries under general anaesthesia supplemented with caudal analgesia.

INTERVENTIONS

Patients were randomised to receive either caudal dexmedetomidine (1 ml kg -1 caudal 0.2% ropivacaine + 1 μg kg -1 caudal dexmedetomidine) or intranasal dexmedetomidine (1 ml kg -1 caudal 0.2% ropivacaine + 1 μg kg -1 intranasal dexmedetomidine).

MAIN OUTCOME MEASURES

The primary outcome was the duration of postoperative analgesia. Other outcomes assessed included postoperative pain scores, peri-operative analgesic consumption, peri-operative haemodynamics, postoperative recovery profile and adverse events for 24 h postoperatively.

RESULTS

The duration of postoperative analgesia in caudal and intranasal group was 527 ± 83 and 545 ± 90 min, respectively ( P   =  0.422). There was a comparable decrease in the intra-operative heart rate. The greater number of episodes of intra-operative hypotension in the caudal group ( P   =  0.016) did not warrant vasopressors. Children in the caudal group were more sedated until 2 h postsurgery following which the sedation scores in both the groups were equivalent. Postoperative pain scores, peri-operative analgesic consumption and the incidence of emergence delirium was comparable. No adverse events were reported in either group.

CONCLUSION

Intranasal dexmedetomidine can be considered a feasible analgesic adjunct to a single-injection caudal block in children undergoing infraumbilical surgeries associated with a smooth recovery profile and no associated adverse effects.

CLINICAL TRIAL REGISTRATION

Clinical Trial Registry of India (CTRI/2022/09/045492; http://www.ctri.nic.in ).