The University Ethics Committee approved the study, and the parents signed written consent forms. Fifty healthy ASA status 1 children, free of any nasopharyngeal or respiratory problems, aged 5-7 years, weighing 15-20 kg, and having 6 or more teeth extracted, were eligible for participation in the study. Exclusion criteria were as follows: the use of analgesics or central nervous system depressants over the previous 24 hours; the use of anticoagulants; hypersensitivity to opioids, benzodiazepines, and ketamine, or any other medication likely to interfere with the study drugs. At a presurgery visit, patients were evaluated for inclusion, and baseline assessments (including a medical history) were performed. Patients were randomly allocated before surgery according to a computer-generated randomization list to 1 of 2 treatment groups. Children were fasted for 8 hours beforehand with only sips of clear fluid allowed 3-4 hours preinduction. In the S/M group, 25 children received intranasal sufentanil 20 |xg (50 |mg/mL, via Go Medical^R nasal spray) and intranasal midazolam 0.3 mg/ kg (5 mg/mL, via a tuberculin syringe in the other nostril) 20 minutes before the induction of anesthesia. In the K/M group, 25 children received intranasal ketamine 5 mgAg (100 mg/mL, via Go Medical nasal spray) and intranasal midazolam 0.3 mg/kg (via a tuberculin syringe in the other nostril) 20 minutes before the induction of anesthesia. Sevoflurane in nitrous oxide and oxygen was used for induction and maintenance of anesthesia. The children were all intubated and a throat pack inserted to protect the airway. The children were allowed to breathe spontaneously. They underwent dental extractions. No local anesthesia was used. A blinded observer/researcher monitored parameters. The blinded observer/researcher remained with the child from prior to drug administration until discharge from the recovery room and was unable to tell which drug combination was being administered. Patients were also observed for adverse effects like nausea, vomiting, itching, and excessive sedation.

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An increasing number of children are undergoing day-case surgery. Children from 3 to 5 years of age may experience significant emotional upset as a result of hospitalization, fear of separation from parents, and unfamiliar surroundings. Children in this age group may not be fully aware of the necessity of their surgical procedure. They are fearful of injections and cannot be easily reassured with an explanation. The primary clinical need in the pediatric population is for a well-tolerated, effective, and expedient analgesic agent that is safe to use. The intranasal administration of opioids may be an alternative route to intravenous, subcutaneous, oral transmucosal, oral, or rectal administration in some patients. Intranasal administration of lipophilic opioids has been shown to be an effective method of administration that is devoid of major side effects.

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