Efficacy and safety of a mixture of ketamine, midazolam and atropine for procedural sedation in paediatric oncology: a randomised study of oral versus intramuscular route

Abstract

To evaluate the efficacy and safety of a mixture of ketamine, midazolam and atropine given orally by comparing the same mixture given through the intramuscular route in children with malignancy undergoing minor invasive procedures. Sixty children, aged between 1 and 10 years, scheduled to undergo minor procedures were randomised into two groups to receive a mixture of ketamine (6 mg/kg), midazolam (0.05 mg/kg) and atropine (0.02 mg/kg) intramuscularly (Group 1) or ketamine (10 mg/kg), midazolam (0.2 mg/kg) and atropine (0.05 mg/kg) orally (Group 2). Sedation score, observer-rated visual analogue scale for pain were noted by an observer blinded to the route of drug administration. Optimum sedation was present in all children in both groups after drug administration, with Group 1 being more deeply sedated than Group 2 at the start of the procedure. Supplementation with intravenous ketamine was required in four children in Group 1 and eight children in Group 2 (P = 0.33). The mean (+/-SD) observer-rated visual analogue scale for pain during the procedure was 8.33 (+/-15.99) and 9.33 (+/-16.39) in Group 1 and Group 2, respectively (P = 0.892). One patient in Group 1 had vomiting after the procedure. There were no differences in proportion of patients with hallucinations and nystagmus in both groups. A mixture of ketamine, midazolam and atropine given orally provides sedation and analgesia similar to that produced by the same drugs given intramuscularly. It offers advantage over the intramuscular route as it is painless and can be given for minor paediatric oncology procedures with appropriate monitoring.