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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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PACTR202111603969039
Phase 2
Recruiting
Trial Details
Pan Africa Clinical Trials Registry โ€ข PACTR202111603969039
Pure Global
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prevention of emergence agitation in children by adding Ketamine or midazolam to bupivacaine caudally
ketamine versus midazolam as adjuvant to caudal bupivacaine for prevention of emergence agitation in children a prospective randomized comparative study

Study Focus

Surgery; Anaesthesia

Sponsor & Location

mansoura university

Omar Mahmoud

Egypt

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 โ€œa disturbance in a childโ€™s 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

Other complications of anaesthesia
Anaesthetic, unspecified
During surgical operation
During surgical operation
During surgical operation

Data Source

Pan Africa Clinical Trials Registry

PACTR202111603969039

Non-Device Trial