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Oral transmucosal midazolam premedication for preschool children
U A Pandit1, P J Collier, S Malviya
1Department of Anesthesiology, C.S. Mott Children's Hospital, Ann Arbor, MI 48109-0211, USA. umapand@umich.edu
Insights
Oral transmucosal midazolam effectively reduces pre-surgery anxiety in young children. This study found midazolam (a sedative) administered via strawberry syrup was well-accepted and improved separation from parents, making it an effective premedicant.
Area of Science:
- Pediatric Anesthesiology
- Pharmacology
- Clinical Trials
Background:
- Preoperative anxiety is common in pediatric patients undergoing surgery.
- Effective premedicants are crucial for improving the perioperative experience in children.
- Oral transmucosal drug delivery offers a non-invasive route for pediatric medication administration.
Purpose of the Study:
- To assess the acceptance and efficacy of oral transmucosal midazolam as a premedicant in pediatric patients.
- To evaluate the use of 0.2 mg x kg(-1) of midazolam in infants and preschool children.
- To compare the effectiveness of midazolam with a placebo in reducing preoperative anxiety.
Main Methods:
- A randomized, prospective, double-blind, placebo-controlled study involving 44 healthy children aged 8 months to 6 years.
- Midazolam (0.2 mg x kg(-1)) mixed with strawberry syrup or plain syrup (placebo) was administered orally in small aliquots.
- Acceptance was measured by willingness to take the medication, and efficacy by ease of separation from parents, assessed by a blinded observer.
Main Results:
- Medication acceptance was high in both groups, with 95% for midazolam and 96% for placebo.
- Separation from parents was significantly more successful in the midazolam group (95%) compared to the placebo group (59%) (P = 0.006).
Conclusions:
- Oral transmucosal midazolam, when administered in strawberry syrup via small aliquots, is well-accepted by infants and preschool children.
- This method of midazolam administration is an effective premedicant for pediatric patients.
- Oral midazolam provides a valuable option for managing preoperative anxiety in young surgical patients.
Purpose:
To evaluate the acceptance and effectiveness of 0.2 mg x kg(-1) of oral transmucosal midazolam as a premedicant in infants and preschool children.
Method:
In a randomized, prospective double-blind placebo controlled study, 44 healthy children, between the ages of eight months to six years, presenting for elective surgery were divided in two groups. The medicated group received 0.2 mg x kg(-1) of injectable midazolam mixed with an equal volume of strawberry syrup and the placebo group received plain syrup 0.08 ml x kg(-1). Medications were placed on the anterosuperior aspect of the child's tongue in 3-5 aliquots of 0.2-0.4 ml. A blinded observer assessed the acceptance of the medication by willingness to open the mouth for the next aliquot and the efficacy of the medication was assessed by ease of separation from the parent.
Results:
Ninety-six percent of the children in the placebo group and 95% in the midazolam group willingly accepted the medication. Separation of children from parents was successful in 95% of the medicated children compared with 59% in the placebo group (P = 0.006).
Conclusion:
Oral midazolam in thick strawberry syrup, administered in small aliquots via the oral transmucosal route was well accepted and proved to be an effective premedicant in infants and preschool children.
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