Nalbuphine as an Adjuvant to Levobupivacaine in Caudal Analgesia in Children
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Ain Shams University
- Enrollment
- 64
- Locations
- 1
- Primary Endpoint
- duration of analgesia
Study Overview
Brief Summary
Caudal anesthesia is the single most important pediatric regional anesthetic technique and is increasingly performed in pediatric regional anesthesia practices. It is preferred in order to relieve intra-operative and postoperative pain in children of all age groups undergoing pelvi-abdominal or lower limbs surgeries using levobupivacaine 0.25%.Various adjuvants have been added to levobupivacaine to prolong postoperative caudal analgesia. Nalbuphine as many opioids can be added in caudal analgesia. This prospective randomized double blind study was done to compare the effects of plain levobupivacaine versus Levobupivacaine plus nalbuphine single-shot for postoperative pain relief in children undergoing hypospadius repair surgery.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 1 Year to 3 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •ASA I, II.
- •Age 1-3 years.
- •Patients scheduled for hypospadias repair surgeries.
Exclusion Criteria
- •ASA III, IV.
- •Signs of infection at site of injection.
- •Known coagulopathy disorder.
- •Mental and / or developmental retardation.
Outcomes
Primary Outcomes
duration of analgesia
Time Frame: 24hours
Time to first analgesia request (TFAR)
Quality of Postoperative analgesia
Time Frame: 24 hours
Face legs activity cry consolablity score (FLACC) (0-10) Score: 0, no pain; 1-3, mild pain; 4-7, moderate pain; 8-10, severe pain
Secondary Outcomes
- analgesic consumption(24 hours)