Comparison of the analgesic effect of oral morphine with that of intravenous morphine in pediatric patients: multicenter open-label randomized blinded prospective clinical study

Abstract

BACKGROUND: Certain children with recurrent episodes of acute nociceptive pain experience chronic pain. In accordance with the recommendations of the World Health Organization, short-acting morphine is the main drug used to relieve severe pain and breakthrough pain. In published studies, morphine provided adequate analgesia in the majority (90%) of the patients; however, no such studies have compared the use of morphine tablets with a control group of pediatric patients. OBJECTIVE: To evaluate the effectiveness and safety of morphine tablets at a dose of 5 mg and compare them with those of morphine given intravenously at a dose of 10 mg/mL in children with severe pain syndrome in the postoperative period. MATERIALS AND METHODS: A multicenter open randomized blind prospective clinical study was conducted in parallel groups of 100 patients aged 3–18 years with severe pain syndrome in the postoperative period between September 21, 2020, and December 15, 2022. Cumulative morphine consumption, visual analog scale analgesic efficacy, patient satisfaction scores, and adverse events (AEs) / serious adverse events (SAEs) were assessed. RESULTS: The comparative analysis of the average values of the total number of doses of an additional analgesic drug administered during treatment with the study drug (group 1)/comparison drug (group 2) in patients of different age groups (cohorts 1, 2, 3) did not reveal significant differences (p=0.05). This finding indicated the equal effectiveness of the used forms of drugs in both groups. Moreover, no significant differences were noted in the development of AEs associated with the study drug (group 1) compared with AEs of the reference drug (group 2) in patients of different age groups (cohorts 1, 2, 3); (p=0.05). CONCLUSION: The study demonstrated the effectiveness and safety of the study drug in tablets in comparison with an injection drug in children with severe pain syndrome.