The efficacy and safety of itopride in feeding intolerance of critically ill patients receiving enteral nutrition: a randomized, double-blind study.

BACKGROUND: Enteral feeding intolerance (EFI) is a frequent problem in the Intensive care unit (ICU) and is associated with poor clinical outcomes leading to worse prognosis in terms of mortality and ICU stay. Nowadays, prokinetic drugs are the mainstay of therapy in EFI. However, available prokinetics have uncertain efficacy and safety profiles. Itopride, is a prokinetic agent which is different and unique from the available prokinetics because of its dual mode of action as well as its tolerability and safety. The current study compared the efficacy and safety of Itopride against metoclopramide for EFI in critically ill patients. Moreover, it tested the utility and applicability of ultrasonography to measure gastric residual volume (GRV) in this population. METHODS: This randomized, double-blind study included 76 EFI patients who were randomly assigned to either Itopride or metoclopramide group. The primary outcome was to measure GRV by ultrasonography. Secondary outcomes included the percentage ratio of enteral feed volume, energy and protein received by patients over 7 days of treatment, ICU length of stay, safety parameters and occurrence of infectious complications or vomiting. RESULTS: Thirty-five patients of each group completed the study. At day 7, itopride significantly decreased GRV compared with metoclopramide group (p = 0.001). Moreover, there was a significant increase in the ratios of received enteral nutrition feed volume, calories, and protein after the one-week therapy in the itopride group more than the metoclopramide group (p = 0.001), (p = 0.002), (p = 0.01), respectively and there were no differences in any secondary outcomes or adverse events between the two groups. CONCLUSION: In critically ill patients with EFI, itopride was well tolerated with superior efficacy to metoclopramide. In addition, we demonstrated that ultrasonography is a simple, non-invasive, inexpensive, and undemanding method for GRV measurements and can offer reliable assessments in the gastric emptying modality. TRIAL REGISTRATION: The trial was registered in ClinicalTrials.gov (NCT03698292). Date: October 5, 2018.

Dexmedetomidine versus Magnesium as Adjuvants to Bupivacaine-Induced Caudal Block in Children: A Randomized, Double-Blinded, Placebo-Controlled, Trial.

BACKGROUND: Caudal block remains fundamental in pediatric anaesthetic practice. It is very useful in a wide range of surgical procedures and has proved to have a remarkable safety record, But one of the major limitations of the single-injection technique is the relatively short duration of postoperative analgesia. Prolongation of caudal analgesia using single-shot technique has been achieved by the addition of various adjuvant. AIM: This work aims to compare magnesium and dexmedetomidine as adjuvants to bupivacaine-induced caudal block in children undergoing lower limb orthopaedic surgery. STUDY DESIGN: Randomized, double-blind trial. SETTINGS: Pediatric or of a tertiary care centre. METHODS: A double-blinded, randomised controlled trial included 36 children, aged between 1 and 7 years, scheduled for lower limb orthopaedic surgery. Patients received general anaesthesia in addition to the caudal block. Patients were divided into three groups: Dexmedetomidine group (n = 12): received 0.5 mL/Kg bupivacaine + 2 mcg/Kg dexmedetomidine, Magnesium group (n = 12): received 0.5 mL/Kg bupivacaine + 50 mg magnesium, and control group (n = 12): received 0.5 mL/Kg bupivacaine + normal saline. Patients were compared according to the duration of analgesia, pain scores, sedation scores, mean arterial pressure, and heart rate. RESULTS: Both magnesium group and dexmedetomidine group showed better analgesic profile (duration of analgesia and pain scores) compared to the control group without significant difference between the two former groups. Dexmedetomidine group showed higher sedation score, lower mean arterial pressure and lower heart rate compared to other groups. CONCLUSIONS: Both magnesium (50 mg) and dexmedetomidine (2 mcg/Kg) improved the analgesic profile of bupivacaine-induced caudal block in children. Dexmedetomidine administration was accompanied with higher sedation score and negative hemodynamic profile.