prevention of emergence agitation in children by adding Ketamine or midazolam to bupivacaine caudally - Trial PACTR202111603969039
Access comprehensive clinical trial information for PACTR202111603969039 through Pure Global AI's free database. This Phase 2 trial is sponsored by mansoura university and is currently Recruiting. The study focuses on Surgery; Anaesthesia.
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Study Focus
Sponsor & Location
mansoura university
Omar Mahmoud
Timeline & Enrollment
Phase 2
Mar 15, 2021
Jan 20, 2022
Summary
Emergence agitation (EA), which is also referred to as emergence delirium in children is a major postoperative issue that increases the risk of patient self harm ,places a burden on nursing staff, and reduces parentsatisfaction with treatmentThe definition of EA is โa disturbance in a childโs awareness of and attention to his or her environment with disorientation and perceptual alterations, including hypersensitivity to stimuli and hyperactive motor behavior in the immediate post-anesthesia period.โ Risk factors for EA include age, preoperative anxiety, patient personality, pain, anesthesia method, and surgical procedure. In cases of EA, patients often remove drains or catheters, causingself-harm. Thus, sedation or restraint by health care providers may be required. Furthermore, this EA is often a particularly unpleasant experience for parents or caregivers. Therefore, various approaches allowing uneventful emergence from anesthesia have been studied. Ketamine and Midazolam both are being used to prevent EA in children mainly through intravenous route.The primary outcome of this study is prevention of EA this outcome will be measured by the pediatric anesthesia emergence delirium scale (PAED). The secondary outcomes are post operative analgesia which will be determined by the face legs activity cry consolability scale (FLACC), time of first analgesic request, 24 hours postoperative analgesic requirement and intraoperative hemodynamics.
ICD-10 Classifications
Data Source
Pan Africa Clinical Trials Registry
PACTR202111603969039
Non-Device Trial

