Clinical trial

Can Caudal Dexmedetomidine Provide Effective Analgesia During Pediatric Inguinoscrotal Surgery?

Name
Dexmedetomidine
Description
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 arms
Trial start
2024-09-01
Estimated PCD
2027-09-01
Trial end
2027-10-01
Status
Not yet recruiting
Treatment
Caudal Bupivacaine injection
- 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.
Arms:
Group B (25 patients)
Caudal Dexmedetomidine Injection
- 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.
Arms:
Group D (25 patients)
Size
50
Primary endpoint
Amount of opioids needed by patients.
Intraoperative (during the surgery)
Amount of opioids needed by patients.
during the first 6 hours postoperative
Time to the first analgesic rescue
during the first 6 hours postoperative
Eligibility criteria
Inclusion Criteria: * ASA-I and ASA-II pediatric patients (age :1-6 years old) * Inguinoscrotal surgeries Exclusion Criteria: * Patient's parent's refusal * Unable to give consent * Known allergy to the study medications * Coagulopathies or on anticoagulant medications * ASA-III or ASA-IV
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 50, 'type': 'ESTIMATED'}}
Updated at
2024-02-13

1 organization

2 products

2 indications

Organization
Benha University
Indication
Anesthesia