Impact of Oral Clonidine on Duration of Opioid and Benzodiazepine Use in Mechanically Ventilated Children: A Randomized, Double-Blind, Placebo-Controlled Study

Document Type : Research article


1 Pediatric Pathology Research Center, Research Institute for Children Health, Mofid Children Hospital, Shahid Behehsti University of Medical Sciences, Tehran, Iran.

2 Pediatric Pathology Research Center, Research Institute for Children Health, Mofid Children Hospital, Shahid Behehsti University of Medical Sciences, Tehran, Iran

3 Cancer Research Center, Semnan University of Medical Sciences, Semnan, Iran.

4 Department of Pharmacology, School of Medicine, Semnan University of Medical Sciences, Semnan, Iran.


Objective: Long term use of opioids and benzodiazepines are associated with important untoward effects. The α2 adrenergic agonist clonidine has sedative effects. Our goal was to study clonidine addition to total doses of fentanyl and midazolam and duration of ventilation in pediatric ICU (PICU).
Methods: This randomized, double-blind, placebo-controlled trial was conducted in PICU of Mofid Children Hospital. Hundred children aged from 2 to 15 years were randomized 1:1 to 5 μg/kg oral clonidine every 6 hours plus 1-5 µg/kg/hr IV fentanyl and 0.05- 0.1 mg/kg/hr IV midazolam or placebo plus 1-5 µg/kg/hr fentanyl and 0.05- 0.1 mg/kg/hr midazolam. Daily use of fentanyl and midazolam were measured. Ramsay sedation score was used for evaluation of sedation.
Results: 96 patients were studied. Patients in placebo group received more midazolam and fentanyl compared with patients in intervention group. Mean total dose of midazolam was 4.3 ± 2.2 mg in the placebo group and 2.7 ± 2.9 mg in the intervention group (P < 0.05). Mean total dose of fentanyl was 34.4 ± 23.1 µg in the placebo group and 18.9 ± 10 µg in the intervention group (P < 0.01). No significant differences were observed in duration of ventilation and length of ICU stay. No case of severe adverse events was seen.
Conclusion: This trial showed a reduction in total doses of midazolam and fentanyl given in ventilated children who were administered clonidine as add-on therapy. Clonidine addition appeared to reduce ICU stay but had no effect on duration of mechanical ventilation.


Main Subjects

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