Clonidine Versus Midazolam Premedication and Postoperative Negative Behavioral Changes in Younger Children: A
Caroline Zickerman1, Ann-Catrin Hult, Lars Hedlund
1From the Department of Surgical and Perioperative Sciences, Anesthesiology and Intensive Care Medicine, Umeå University, Umeå, Sweden.
Insights
Clonidine did not show superiority over midazolam in preventing negative behavioral changes (NBCs) in children after surgery. Both premedication options were equally effective in reducing postoperative behavioral issues in young patients.
Area of Science:
- Pediatric Anesthesiology
- Behavioral Psychology
Background:
- Postoperative negative behavioral changes (NBCs) are common in children.
- Midazolam and clonidine are frequently used premedications to mitigate these changes.
- Clonidine, an alpha-2 adrenergic agonist, has gained popularity as a preanesthetic sedative.
Purpose of the Study:
- To compare the efficacy of clonidine versus midazolam in preventing new postoperative negative behavioral changes in children.
- To assess the impact of premedication on children's behavior following outpatient surgery.
Main Methods:
- A prospective, randomized, controlled, blinded study involving 115 children (24-95 months) undergoing ENT surgery.
- Participants received either oral midazolam (0.5 mg/kg) or oral clonidine (4 µg/kg) as premedication.
- Postoperative NBCs were assessed using the Post Hospital Behavior Questionnaire (PHBQ) at 1 week, 1 month, and 6 months; preinduction anxiety was measured using the modified Yale Preoperative Anxiety Scale (mYPAS).
Main Results:
- No statistically significant difference in the proportion of children experiencing more than 3 NBCs at 1 week between the clonidine (20%) and midazolam (13%) groups (P = .32).
- A significantly higher level of preinduction anxiety was observed in the clonidine group (71%) compared to the midazolam group (21%) (P < .001).
Conclusions:
- Clonidine and midazolam demonstrated no significant difference in preventing negative behavioral changes in children one week after surgery.
- Midazolam was associated with lower preinduction anxiety levels compared to clonidine.
- Neither medication showed a clear advantage for the primary outcome of behavioral changes at one week.
Background:
Postoperative 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).
Methods:
This 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).
Results:
The 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).
Conclusions:
These 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.
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