Onset time for pharmacologic premedication with clonidine as a nasal aerosol: a double-blind, placebo-controlled, randomized trial

Objectives/Aim: To investigate whether nasal aerosol clonidine can reduce the onset time of preoperative sedation.

Background: Premedication is common in the pediatric population, but the optimal agent and administration route is still a matter of debate. Clonidine has many beneficial effects in the perioperative period. Clonidine nasal drops produce a similar sedative effect as after oral administration but do not reduce the onset time. Nasal aerosol administration of drugs is generally more effective than drops and an option to decrease the onset time of clonidine.

Methods: Pediatric ASA status 1 and 2 patients were randomized to receive placebo (P), clonidine 3–4 μg kg⁻¹ (C4), or clonidine 7–8 μg kg⁻¹ (C7) as a nasal aerosol. Acceptance of administration, pre- and postoperative sedation, and adverse events were assessed.

Results: A total of 60 patients were enrolled with a median age of 3.5 years (range 0.7–6.9) and median weight of 14.8 kg (range 10–25). In the C7 group, 55% of the children were found adequately sedated at 30 min as compared to 32% in the C4 group (P = 0.1202). At 45 min, adequate sedation was seen in 65% of the patients in both C4 and C7 groups, which were both found to be significantly higher compared with the placebo control group (14%) (P-values = 0.0027 and 0.0013, respectively). The postoperative sedation profile did not differ between the three study groups.

Conclusions: Clonidine administered as nasal aerosol (3–8 μg kg⁻¹) was not found to achieve adequate preoperative sedation within 30 min of administration. Despite its sedative properties, no prolongation of postoperative sedation was noted compared with placebo.