Effect of Caudal Nalbuphine on Postoperative Analgesia in Children

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02618876

Enrollment

Registered

2015-12-02

Start date

2015-11-30

Completion date

2019-12-31

Last updated

2020-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain

Brief summary

Nalbuphine as an adjuvant to bupivacaine caudal anesthesia for postoperative analgesia in children undergoing Hypospadias repair. 2 groups, 30 patients each

Interventions

DRUGNalbuphine plus Bupivacaine

Addition of caudal Nalbuphine to the standard Bupivacaine

DRUGBupivacaine

Caudal Bupivacaine is the standard of care will be considered as a control

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

2 Years to 10 Years

Healthy volunteers

Inclusion criteria

* Children undergoing elective Hypospadias repair * with American Society of Anesthesiologists (ASA) physical status I * age 2-10 years

Exclusion criteria

* Coagulation disorder * allergy to study medications * major malformations of the lower spine or meninges or any cutaneous or subcutaneous lesion at the site of injection.

Design outcomes

Primary

Measure	Time frame
Postoperative pain intensity Measured by Face, Legs, Activity, Cry & consolability (FLACC) pain scale	During 24 h in the postoperative period

Secondary

Measure	Time frame
Cortisol level	6 hours

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026