European journal of anaesthesiology · 2025
Comparison of analgesic efficacy and safety of caudal dexmedetomidine versus intranasal dexmedetomidine in paediatric infraumbilical surgeries: A randomised controlled trial.
СтатьяРандомизированное исследованиеСравнительное исследованиеEquivalence TrialНазвание и аннотация: Перевод пока не подготовлен
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Agarwal Ayushi, Shah Shreya B, Sinha Renu, Prasad Ganga, Prakash Kelika, Goel Prabudh
Аннотация
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 ).
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 ).