Randomized Controlled Trial
For paediatric anaesthesia premedication comparing midazolam 0.5 mg/kg to clonidine 4 µg/kg, there is no clinical or statistical difference in negative behaviour changes in 2 to 8 year olds at 1 week. Midazolam did however show significantly lower pre-induction anxiety.pearl
- Caroline Zickerman, Ann-Catrin Hult, Lars Hedlund, Ola Winsö, Göran Johansson, and Michael Haney.
- From the Department of Surgical and Perioperative Sciences, Anesthesiology and Intensive Care Medicine, Umeå University, Umeå, Sweden.
- Anesth. Analg. 2022 Aug 1; 135 (2): 307-315.
BackgroundPostoperative negative behavioral changes (NBCs) are common among children, but risk for this is thought to be reduced with premedication. Midazolam has for many years been a standard premedication for children. More recently, the alpha-2 adrenergic agonist clonidine has also become popular as a preanesthetic sedative. We hypothesized that clonidine was superior to midazolam for limiting new NBCs in children as assessed using the Post Hospital Behavior Questionnaire (PHBQ).MethodsThis was a prospective, randomized, controlled, blinded study, including 115 participants aged 24 to 95 months and their parents. The participants underwent ear, nose, or throat outpatient surgery and were randomly allocated to premedication with oral midazolam 0.5 mg/kg or oral clonidine 4 µg/kg. Participants were anesthetized by protocol. At home, later, parents were asked to complete the PHBQ assessment instrument for postoperative NBCs for the participants 1 week, 1 month, and 6 months after the surgery. A secondary outcome, preinduction anxiety, was assessed using modified Yale Preoperative Anxiety Scale (mYPAS).ResultsThe primary outcome, more than 3 NBCs in an individual case at 1 week, showed no difference in proportions between treatment in the clonidine group compared to the midazolam group, (12/59 or 20% vs 7/56 or 13%, respectively, odds ratio 1.39, 95% confidence interval [CI], 0.75-2.58; P = .32). A secondary result showed a higher preinduction anxiety level in the clonidine compared to the midazolam group (mYPAS >30, 43/59 or 71% vs 12/56 or 21%, respectively; P < .001).ConclusionsThese results did not show a clinical or statistically significant difference, with respect to the primary outcome of behavior changes at 1 week, between the cohorts that received midazolam versus clonidine as a premedication.Copyright © 2022 International Anesthesia Research Society.
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