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Intravenous Dexmedetomidin on Postoperative Pain After Hypospadias Repair in Children

Primary Purpose

Postoperative Pain

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Dexmedetomidine
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Pain focused on measuring dexmedetomidine, ketorolac

Eligibility Criteria

1 Year - 7 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • ASA physical status I & II.
  • Age between 2 years & 6 years old.
  • Body weight below 30 Kg.

Exclusion Criteria:

  • Any contraindications to any drug used
  • patients refusal
  • recurrent surgery

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    group 1

    group 2

    Arm Description

    ketorolac group: number = 30 patients , time : after intubation, dose 0.9 mg/kg

    Dexmedetomidine group: number : 30 patients, time : after intubation, dose 1 μg/kg

    Outcomes

    Primary Outcome Measures

    Total analgesic consumption in the first 24 hours after surgery
    Total analgesic consumption in the first 24 hours after surgery

    Secondary Outcome Measures

    Full Information

    First Posted
    January 4, 2022
    Last Updated
    January 4, 2022
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05194904
    Brief Title
    Intravenous Dexmedetomidin on Postoperative Pain After Hypospadias Repair in Children
    Official Title
    Intrtavenous Ketorolac Versus Intravenous Dexmedetomidine for Postoperative Analgesia After Hypospadius Repair
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 2022 (Anticipated)
    Primary Completion Date
    July 2023 (Anticipated)
    Study Completion Date
    November 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
    Product Manufactured in and Exported from the U.S.
    No

    5. Study Description

    Brief Summary
    This study aimed to evaluate the efficacy of intravenous ketorolac versus dexmedetomidine as analgesia after Hypospadias repair surgery to determine the optimal procedure for pain control and postoperative reduction of analgesic use
    Detailed Description
    The guidelines of the American Society of Anesthesiologists (ASA) for the treatment of pain in the perioperative period define postoperative acute pain as pain present in surgical patients following the procedure.1 Almost 80% of patients undergoing surgery experience postoperative pain, and 80% of them reported moderate to severe pain intensity.2 Inadequate management of postoperative pain may lead to development of complications and prolonged recovery time with increased morbidity and mortality rates in adults.3,4 Although equivalent data for children are not available, this evidence warrants caution in pediatric population too. Appropriate treatment of postoperative pain contributes to shorter time of hospitalization, lower hospital costs, and increased level of patient satisfaction. There is enough evidence that an ineffective treatment of postoperative pain is in positive correlation with delayed wound healing, and the negative development of pain perception and chronic pain in the future.5,6 Hypospadias repair surgery is an invasive procedure whose postoperative phase is very painful.7 Pain management can be counted as an important step in all surgeries, especially in pediatric and neonatal surgical procedures. It has been reported that up to 40% of the children undergoing surgeries suffer from moderate to severe post-operative pain.8 In addition to the significance of post-operative pain management in the quality of life and satisfaction of the patients, it plays a great role in minimizing the complications and improving the surgery outcome in certain types of surgeries. In hypospadias surgery, post-operative pain results in manipulation of wounds and consequent infection, hemorrhage, and wound dehiscence.9 These complications cause significant preventable morbidities. Post-operative pain management also alleviates the local and systemic inflammation resulting in more favorable outcomes.10 Ketorolac is a non-steroidal anti-inflammatory drug (NSAID) that has an analgesic efficacy similar to commonly used opioids, and that recently has found wide acceptance in the treatment of postoperative pain in a variety of surgical procedures. Ketorolac is used for moderate pain relief; it may be used to treat severe pain when associated with opioids, reducing the opioid dose. The advantage of this association is the reduction of opioid side effects such as respiratory depression, pruritus, urinary retention, sedation and nausea . 11,12,13 Dexmedetomidine is a highly selective α2-adrenergic receptor agonist commonly used in neurosurgery . The advantages of dexmedetomidine include reducing perioperative catecholamine to maintain intraoperative hemodynamic stability and exerting the unique neuroprotective effects by inhibiting the release of glutamate, pro-apoptotic proteins, and pro-inflammatory cytokines. In addition, previous studies have shown that it can reduce sedative and opioid consumption and provide better analgesic effects with lesser concern for side effects than opioids

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postoperative Pain
    Keywords
    dexmedetomidine, ketorolac

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Single Group Assignment
    Model Description
    This is a prospective randomised clinical study designed to assess the effect of intravenous ketorolac versus intravenous dexmedetomidin on postoperative pain after hypospadias repair in children
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    group 1
    Arm Type
    Active Comparator
    Arm Description
    ketorolac group: number = 30 patients , time : after intubation, dose 0.9 mg/kg
    Arm Title
    group 2
    Arm Type
    Active Comparator
    Arm Description
    Dexmedetomidine group: number : 30 patients, time : after intubation, dose 1 μg/kg
    Intervention Type
    Drug
    Intervention Name(s)
    Dexmedetomidine
    Other Intervention Name(s)
    ketorolac
    Intervention Description
    This is a prospective randomised clinical study designed to assess the effect of intravenous ketorolac versus intravenous dexmedetomidin on postoperative pain after hypospadias repair in children
    Primary Outcome Measure Information:
    Title
    Total analgesic consumption in the first 24 hours after surgery
    Description
    Total analgesic consumption in the first 24 hours after surgery
    Time Frame
    first 24 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    1 Year
    Maximum Age & Unit of Time
    7 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: ASA physical status I & II. Age between 2 years & 6 years old. Body weight below 30 Kg. Exclusion Criteria: Any contraindications to any drug used patients refusal recurrent surgery
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Muhammed Samir Ghitany, master
    Phone
    +201096594245
    Email
    muhammadsamir248@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Khaled Abdel-Baki Abdel-Rahman, prof
    Phone
    +201008182061
    Email
    khaledbaky@aun.edu.eg

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    31623841
    Citation
    Gao J, Sun Z, Xiao Z, Du Q, Niu X, Wang G, Chang YW, Sun Y, Sun W, Lin A, Bresnahan JC, Maze M, Beattie MS, Pan JZ. Dexmedetomidine modulates neuroinflammation and improves outcome via alpha2-adrenergic receptor signaling after rat spinal cord injury. Br J Anaesth. 2019 Dec;123(6):827-838. doi: 10.1016/j.bja.2019.08.026. Epub 2019 Oct 14.
    Results Reference
    background
    PubMed Identifier
    3729064
    Citation
    Blaise G, Roy WL. Postoperative pain relief after hypospadias repair in pediatric patients: regional analgesia versus systemic analgesics. Anesthesiology. 1986 Jul;65(1):84-6. doi: 10.1097/00000542-198607000-00016. No abstract available.
    Results Reference
    result

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    Intravenous Dexmedetomidin on Postoperative Pain After Hypospadias Repair in Children

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