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Novel Methods for Intranasal Administration Under Inhalation Anesthesia to Evaluate Nose-to-Brain Drug Delivery
Published on: November 14, 2018
Intranasal clonidine vs. midazolam as premedication in children: a randomized controlled trial
Sukanya Mitra1, Sunita Kazal, Lakesh K Anand
1Department of Anaesthesia and Intensive Care, Government Medical College and Hospital, Chandigarh, India. Correspondence: Dr Sukanya Mitra, 203-B, New Type-V Flats, Sector 24-A, Chandigarh 160023, India. drsmitra12@yahoo.com.
Objective:
To compare anxiolysis produced by intranasal clonidine with intranasal midazolam as premedication in children undergoing surgery.
Design:
Double-blind randomized controlled study.
Setting:
Tertiary-care hospital, July 2009 to June 2010.
Patients:
60 American Society of Anesthesiologists physical status I-II surgical patients aged 1-10 yr.
Intervention:
Participants randomly allocated to receive either intranasal clonidine 4 mcg/kg (Group I) with atropine or intranasal midazolam 0.3 mg/kg (Group II).
Outcome Measures:
Primary: satisfactory anxiolysis at 30 min after drug administration. Secondary: satisfactory mask acceptance, times of onset of sedation and anxiolysis, drug acceptance, level of sedation, wake-up score and side effects.
Results:
All children achieved satisfactory anxiolysis at 30 min. Group I fared significantly better than GroupII on mask acceptance (100% in Group I vs. 80% in Group II; P=0.024), drug acceptance (93% vs. 13%; P<0.001) and proportion of patients with satisfactory wake up scores (100% vs. 53%; P<0.001). Group II patients had significantly faster onset of sedation (median 10 min vs. 15 min; P<0.05) but not that of anxiolysis compared to Group-I (median 10 min for both groups; P>0.05). Side effects were significantly more frequent in Group II.
Conclusions:
Though intranasal midazolam produced faster sedation, both the drugs produced satisfactory anxiolysis at 30 min.
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