CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 60 enrolled
Drug / intervention
Nalbuphinedrug
Likely dose
Nalbuphine 1mlfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03476772
NCT03476772N/ACompleted

Nalbuphine as an Adjuvant to Caudal Bupivacaine for Postoperative Analgesia in Children Undergoing Hypospadius Repair

Assiut University·interventional·Posted Mar 26, 2018·Updated Mar 24, 2021

In Brief

A clinical study evaluating Nalbuphine for Post Operative Pain. Completed, enrolled 60 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesEgypt
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedMar 26, 2018
Enrollment StartMar 1, 2018
Primary CompletionMar 1, 2020
Study CompletionOct 1, 2020
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 8.3 years ago

Interventions

Nalbuphinedrug

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.