Caudal Bupivacaine injection
Drug- Group B (n =25): In this group, and after induction of general anesthesia, pediatric patients will receive a caudal injection of bupivacaine 0.125 % in a dose of 1ml/kg.
NCT Number: NCT05902780
The goal of this clinical trial is to evaluate if caudal dexmedetomidine can provide effective analgesia during inguinoscrotal surgeries in pediatrics, if used caudally alone (and not as an adjunct to caudal bupivacaine).
The main question it aims to answer is:
* Can caudal dexmedetomidine provide effective analgesia? Participants will be pediatrics aged from 1 to 6 years ASA-I and ASA-II undergoing inguinoscrotal surgeries.
- A total of 50 pediatric patients who will undergo inguinoscrotal surgery will be allocated randomly into 2 equal groups: * Group B (n =25): In this group, and after induction of general anesthesia, pediatric patients will receive a caudal injection of bupivacaine 0.125 % in a dose of 1ml/kg. * Group D (n =25): In this group, and after injection of general anesthesia, pediatric patients will receive a caudal injection of dexmedetomidine in a dose of 1.5 mcg/kg.
Trial opening soon.
Get Notified1 year–6 year
All sexes
Interventional
Not applicable
In contrast to other sedative agents, dexmedetomidine, by acting on α2 receptors in the locus caeruleus, has potential analgesic effects without respiratory depression.
Ethical consideration :
The study protocol will be approved by the Institutional Research Ethics Committee. Informed written consent will be obtained from all parents of the pediatric patients, after being explained the purpose of the study and will be ensured strict confidentiality. They will be given the option of not participating in the study if they do not want to.
Type and design of the study:
A total of 50 pediatric patients who will undergo inguinoscrotal surgery will be allocated randomly into 2 equal groups:
Group B (n =25): In this group, and after induction of general anesthesia, pediatric patients will receive a caudal injection of bupivacaine 0.125 % in a dose of 1ml/kg Group D (n =25): In this group, and after induction of general anesthesia, pediatric patients will receive a caudal injection of dexmedetomidine in a dose of 1.5 mcg/kg.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Intraoperative (during the surgery)
How much opioids in mcg/kg will the patient needs
Time frame: during the first 6 hours postoperative
How much opioids in mcg/kg will the patient needs
Time frame: during the first 6 hours postoperative
Measure time in minutes (min) till the patient needs opioids for the first time postoperative
Time frame: Preoperative,Intraoperative and 2 hours postoperative
Measure blood pressure in mmHg of the patient every 10 min
Time frame: Preoperative, intraoperative, and 2 hours postoperative
Measure heart rate in beat/min every 10 min
Time frame: Intraoperative with extubation
The incidence of emergence agitation is high in children, the level of agitation will be assessed through Paediatric Anesthesia Emergence Delirium Scale (PAED SCALE) which consist of 5 criteria that are scored using 5-point scale. The scores of each criterion are added to make a total score. The maximum achieved score is 20.
Time frame: 2 hours Postoperative every 10 min
Measure respiratory rate in breath/ min
Benha University
Other
Can Caudal Dexmedetomidine Provide Effective Analgesia During Pediatric Inguinoscrotal Surgery?
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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