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

Primary Purpose

Agitation, Emergence, Post Operative Pain

Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Nalbuphine
Bupivacain
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Agitation, Emergence

Eligibility Criteria

2 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Nalbuphine

    Bupivacaine

    Arm Description

    Outcomes

    Primary Outcome Measures

    Effect of caudal nalbuphine on postoperative emergence agitation according to Pediatric Anasthesia emergence delirium (PAED)
    PAED ( The pediatric anesthesia emergence delirium scale)

    Secondary Outcome Measures

    Postoperative pain assessment according to Modified Children's Hospital of Eastern Ontario Pain Scale (modified CHEOPS)

    Full Information

    First Posted
    January 18, 2022
    Last Updated
    February 8, 2022
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05245721
    Brief Title
    Effect of Caudal Nalbuphine on Postoperative Emergence Agitation in Pediatrics Undergoing Infra-umbilical Surgeries
    Official Title
    Effect of Caudal Nalbuphine on Postoperative Emergence Agitation in Pediatrics Undergoing Infra-umbilical Surgeries
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 2022 (Anticipated)
    Primary Completion Date
    January 2023 (Anticipated)
    Study Completion Date
    February 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Agitation, Emergence, Post Operative Pain

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    Care Provider
    Allocation
    Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Nalbuphine
    Arm Type
    Active Comparator
    Arm Title
    Bupivacaine
    Arm Type
    Active Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Nalbuphine
    Intervention Description
    Caudal nalbuphine injection in pediatrics undergoing infra-umbilical surgeries
    Intervention Type
    Drug
    Intervention Name(s)
    Bupivacain
    Intervention Description
    Caudal bupivacaine in pediatrics undergoing infra-umbilical surgeries
    Primary Outcome Measure Information:
    Title
    Effect of caudal nalbuphine on postoperative emergence agitation according to Pediatric Anasthesia emergence delirium (PAED)
    Description
    PAED ( The pediatric anesthesia emergence delirium scale)
    Time Frame
    Up to 2 hours postoperative
    Secondary Outcome Measure Information:
    Title
    Postoperative pain assessment according to Modified Children's Hospital of Eastern Ontario Pain Scale (modified CHEOPS)
    Time Frame
    For 24 hours postoperative

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    2 Years
    Maximum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Rehab Adel Ebrahim
    Phone
    01099070718
    Email
    Adelrehab273@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mohamed Fathy Mostafa, Assistant professor
    Phone
    01001123062
    Email
    mo7_fathy@yahoo.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

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

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