Abstract
OBJECTIVE: To compare the safety and efficacy of two doses of oral midazolam, and to assess the drug induced amnesia obtained, when used for conscious sedation of children undergoing minor...
Highlights
MethodsA prospective, randomised, double blinded trial of a convenience sample of children was designed and ethics committee approval granted
In the first limb of the trial, children were randomised to receive a dose of 0.2 mg/kg or 0.5 mg/kg of oral midazolam
When we compared procedures performed on the face with other procedures, we found that the anxiety score increased significantly during the procedure in 14 of 22 children requiring facial procedures compared with six out of 28 in the non-facial group, a difference of 42% (95% confidence interval 17 to 67, p=0.05)
Summary
A prospective, randomised, double blinded trial of a convenience sample of children was designed and ethics committee approval granted. Patients were excluded from the trial if they had received sedative medication in the previous 24 hours, had disabling respiratory disease, a coincidental head injury requiring hospital admission, known allergy to midazolam, or concurrent erythromycin treatment (due to drug interaction). Patient selection was designed to resemble, as closely as possible, the wide range of situations encountered in daily practice in the A&E department. The need for sedation was determined by the degree of distress already present, or that anticipated considering the procedure about to be undertaken. This was determined by mutual agreement of the triage nurse, primary nurse, and middle grade or consultant level doctor, not by written selection criteria. All patients received analgesia and/or local anaesthesia as necessary
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