Efficacy of Dexmedetomidine Versus Morphine as an Adjunct to Bupivacaine in Caudal Anesthesia.
- Registration Number
- NCT04445636
- Lead Sponsor
- Cairo University
- Brief Summary
The aim of this study is to compare the duration of postoperative analgesia, and any side effects of caudal dexmedetomidine versus morphine in combination with bupivacaine in pediatric patients undergoing thoracic surgeries.
- Detailed Description
The patients will be randomized in a blinded fashion to get enrolled into 2 equal groups: Group A patients (n =25) will receive caudal epidural analgesia using dexmedetomidine with bupivacaine, whereas Group B patients (n = 25) will receive caudal epidural analgesia using morphine with bupivacaine.
Randomization will be achieved by using an online random number generator. Patient codes will be placed into sequentially numbered sealed opaque envelopes by a research assistant who is not involved in the study. An anesthesia resident not involved in patient management will be responsible for opening the envelope. The anesthesia resident will prepare the study drug according to the instructions contained within each envelope and give it to the anesthesiologist.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- ASA I, II, III.
- Patients undergoing lung cyst excision.
- Patients undergoing Patent Ductus Arteriosus ligation.
- Preoperative mechanical ventilation.
- Preoperative inotropic support
- History of mental retardation or delayed development that may interfere with pain intensity assessment
- Known or suspected coagulopathy,
- Any congenital anomalies of the sacrum or any infection at the site of injection.
- Known or suspected allergy to any of the studied drugs.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dexmedetomidine group Dexmedetomidine A group which will receive dexamedetomidine as an adjunct to bupivacaine used in caudal anesthesia. Morphine group Morphine A group which will receive morphine as an adjunct to bupivacaine used in caudal anesthesia.
- Primary Outcome Measures
Name Time Method Duration of postoperative analgesia in hours. 3 months Duration of postoperative analgesia in hours.
- Secondary Outcome Measures
Name Time Method Opioid consumption in the first 24 hours post- operative. 3 months Opioid consumption in the first 24 hours post- operative.
The duration of ICU stay in days 3 months The duration of ICU stay in days
Pain score FLACC from 0 to 6 3 months Pain score FLACC from 0 to 6
Post operative heart rate 3 months Postoperative heart rate in beat per minute
Trial Locations
- Locations (1)
Cairo University Hospitals
🇪🇬Cairo, Egypt