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Completed

NCT Number: NCT02618876

Effect of Caudal Nalbuphine on Postoperative Analgesia in Children

Nalbuphine as an adjuvant to bupivacaine caudal anesthesia for postoperative analgesia in children undergoing Hypospadias repair.

2 groups, 30 patients each

Completed

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

2 year–10 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Assiut University Hospital

Asyut, 71515, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nalbuphine plus Bupivacaine

Drug

Addition of caudal Nalbuphine to the standard Bupivacaine

Bupivacaine

Drug

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

Primary outcomes

  1. Postoperative pain intensity Measured by Face, Legs, Activity, Cry & consolability (FLACC) pain scale

    Time frame: During 24 h in the postoperative period

Secondary outcomes

  1. Cortisol level

    Time frame: 6 hours

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Dec 2, 2015
Registry last updated
Apr 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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