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Nalbuphine Plus Caudal Bupivacaine in Hypospadius Repair

NCT03476772 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2021-03-24

No results posted yet for this study

Summary

Caudal aneasthesia for pediatric surgery was first reported in 1933. Since then, studies have described the indications for pediatric caudal block, the level of analgesia, doses, advantages and disadvantages of this technique.

In children, caudal anesthesia is most effectively used as adjunct to general aneasthesia and has an opioid-sparing effect, permitting faster and smoother emergence from aneasthesia.

A single shot caudal anesthesia provides relatively brief analgesia for 4 to 8 hours depending on the agent used. Prolongation of anesthesia can be achieved by adding various adjuvants, such as opioids and nonopioids such as clonidine, ketamine, midazolam, and neostigmine,with varying degrees of success.

Conditions

  • Post Operative Pain

Interventions

DRUG

Nalbuphine

Children will be randomly assigned into 2 groups of 30 patients each. They will receive caudal anesthesia using bupivacaine 0.25% 1ml/kg plus 2 ml normal saline in the control group, bupivacaine 0.25% 1ml/kg plus nalbuphine 0.1 mg/kg in 2 ml solution in the nalbuphine group.

Sponsors & Collaborators

  • Assiut University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
10 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-01
Primary Completion
2020-03-01
Completion
2020-10-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03476772 on ClinicalTrials.gov