Safety and efficacy of oral Triclofos in the ophthalmic evaluation of children with pediatric glaucoma: An observational study.

Purpose: Oral Triclofos is widely used as a sedative agent in children. However, the role of Triclofos as a sedative agent in children undergoing ophthalmological procedures has not been adequately studied. The aim of this study was to determine the safety and efficacy of oral Triclofos in children suffering from pediatric glaucoma who were undergoing ocular examination. Methods: 80 children aged less than 5 years were assessed for eligibility for the trial after taking hospital ethical committee approval. The children were administered 80 mg/kg of oral Triclofos and Ramsay sedation score was measured every 5 min starting from 20 min after administration of the drug. If the child was not adequately sedated after 30 min, additional dose of 05 mg/kg was administered every 5 min till 60 min of drug administration. The procedure was considered a failure and general anesthesia (GA) administered if Ramsay sedation score was ≤4 after 60 min of initial drug administration. Heart rate and arterial oxygen saturation were measured throughout the period of sedation. The duration of sedation and incidence of side effects was also noted. Results: A total of 73 patients underwent the study. The mean age of children was 23.4 months (SD - 14.72) and mean weight was 12 kg (SD - 3.84). The mean dose of Pedicloryl (Triclofos) used was 83.8 mg/kg and the median duration of onset was 25 min. 64 children completed examination successfully, 2 children had to be administered GA during the procedure. There were no major side effects. Conclusion: Administration of oral Triclofos in a dose of 80 mg/kg body weight was safe and effective in children less than 5 years of age undergoing ocular examination.