Effect of Caudal Nalbuphine on Postoperative Emergence Agitation in Pediatrics Undergoing Infra-umbilical Surgeries

Overview

Effect of caudal nalbuphine on postoperative emergence agitation in pediatrics undergoing infra-umbilical surgeries and pain assessment

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Single (Care Provider)
  • Study Primary Completion Date: January 2023

Interventions

  • Drug: Nalbuphine
    • Caudal nalbuphine injection in pediatrics undergoing infra-umbilical surgeries
  • Drug: Bupivacain
    • Caudal bupivacaine in pediatrics undergoing infra-umbilical surgeries

Arms, Groups and Cohorts

  • Active Comparator: Nalbuphine
  • Active Comparator: Bupivacaine

Clinical Trial Outcome Measures

Primary Measures

  • Effect of caudal nalbuphine on postoperative emergence agitation according to Pediatric Anasthesia emergence delirium (PAED)
    • Time Frame: Up to 2 hours postoperative
    • PAED ( The pediatric anesthesia emergence delirium scale)

Secondary Measures

  • Postoperative pain assessment according to Modified Children’s Hospital of Eastern Ontario Pain Scale (modified CHEOPS)
    • Time Frame: For 24 hours postoperative

Participating in This Clinical Trial

Inclusion Criteria

  • Age 2_12 years – Both genders – ASA I_II – Children undergoing infra-umbilical surgeries Exclusion Criteria:

  • Guardians refusal – congenital anomalies at the lower spine or meringues – Increased intracranial pressure – Skin infection at site of injection – Bleeding diathesis – Known allergy to any drugs used

Gender Eligibility: All

Minimum Age: 2 Years

Maximum Age: 12 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Assiut University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Rehab Adel Ebrahim Okely, Assistant lecturer – Assiut University
  • Overall Contact(s)
    • Rehab Adel Ebrahim, 01099070718, Adelrehab273@gmail.com

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