Assessing the Safety of Ketamine as a Procedural Sedative in Paediatric Dentistry: A Comparative Study with Midazolam.

Abstract

Sedation has been employed to improve patient's cooperation. This has contributed to quality of treatments as well as improving the patients' and practitioners' experience during some procedures especially among children. The price of some of the newer sedatives can hamper the use in resource-constraint environments, hence the need to explore other cost-effective options. We compared the safety of oral ketamine against oral midazolam among 100 ASA I and II children aged between 3 and 7 years requiring dental treatments in a tertiary hospital in Lagos, Nigeria. The patients were divided into 2 equal groups by balloting using the opaque envelope method. Group A received Ketamine (7.5 mg / kg) while group B received Midazolam (0.75 mg / kg). The intravenous formulation was mixed with apple juice and administered orally. The patient's vital signs were monitored and the behaviour during procedure was assessed using the Frankl behaviour rating scale. Time to respond to verbal stimulus was recorded. The demographic characteristics and ASA status were similar between the 2 groups (p>0.05). the behaviour of the patients was better among the children in the midazolam group (p=0.026). the ease of administration of local anaesthesia (p=0.012) and examination of the buccal cavity after the procedure (p=0.019) was better in the ketamine group but there was no significant difference in the overall assessment of adequacy of sedation (p= 0.196). The trend of vital signs was similar between the 2 groups (P>0.05). Recovery was longer in the ketamine group (p=0.001). Side effects like vomiting, nystagmus, hypersecretion and somnolence, were significantly higher among the ketamine group, p<0.05. there was no significant difference in the acceptability of both drugs to the dental surgeons and the guardians of the patients (p= 0.093 and 0.308, respectively). Both drugs provided adequate conditions for complete treatments in the study groups. Although the side effect profile was better in the midazolam group, both were acceptable to both dental practitioners and the guardians of the patients.