Analgesic Effects of Caudal S-ketamine for Supplementation of Ropivacaine Caudal Analgesia in Children With Hypospadias

Caudal S-ketamine

Caudal analgesia with ropivacaine is commonly used in sub-umbilical pediatric surgery. However, increasing the dosage of ropivacaine has not been found to prolong the action significantly while complications will be serious. Ketamine as an additive to caudal administration had been shown to prolong the duration of postoperative analgesia, while the analgesic effectiveness of S-ketamine, the S(+)-enantiomer of ketamine with less possibility to induce psychomotor disturbances, is not clear. In this prospective randomized double-blind clinical trial , the investigators aimed to study the effect of S-ketamine as additive on the duration of caudal analgesia.

2023-06-20

2025-04-30

2025-05-01

Recruiting

Early phase I

44

Inclusion Criteria: * informed parent consent, ASA I or II children, between 3months and 18 years of age,and weighing \<28kg, scheduled for elective hypospadias surgery with general anesthesia will be recruited. Exclusion Criteria: * Patients who have congenital abnormalities of lower spine and meninges. * Patients with hypersensitivity to any local anesthetics * Children with coagulation disorders * Presence of Infections at puncture sites * Preexisting neurological disease * Refusal to consent by parent/guardian

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel Assignment', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': 'The Patients allocated to study groups using computer generates random list \\& group assignment is sealed in sequentially numbered opaque envelopes that open after induction of anesthesia.', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 44, 'type': 'ESTIMATED'}}

2023-10-30