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Effect of Steroids on Post-tonsillectomy Morbidities

Primary Purpose

Postoperative Pain, Postoperative Nausea and Vomiting

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
IV dexamethasone
Oral prednisolone
Paracetamol
IV saline
Sponsored by
King Fahd General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Postoperative Pain focused on measuring Dexamethasone, Prednisolone, Tonsillectomy Nausea, Pain, Postoperative, Postoperative Nausea and Vomiting, Randomized controlled trial, Post-tonsillectomy pain, delayed feeding

Eligibility Criteria

5 Years - 20 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients in the waiting list for tonsillectomy under general anesthesia who accepted to participate in the study.

Exclusion Criteria:

  • Patients who are allergic to steroids or those who have medical conditions which contraindicate the use of steroid i.e diabetes mellitus, gastritis, or hypertension and those who were on exogenous steroid supplements.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    IV dexamethasone and oral Prednisolone

    Placebo

    Arm Description

    Single dose of intravenous dexamethasone given immediately following surgery (0.15 mg/kg), followed by oral Prednisolone (0.25mg/kg/day for 7 days then tapering for next 7 days) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).

    Placebo (IV saline) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).

    Outcomes

    Primary Outcome Measures

    Maximum Severity of Post-operative Pain
    5 grades (pain free, low disability and low intensity, low disability and high intensity, high disability and moderate intensity, high disability and severly limiting)
    Duration of Post-operative Pain
    4 selections (1 day, 2 days, 3 days, if more specify)
    Occurence of Post-operative Nausea
    Postoperative nausea occurence (yes, no)
    Onset of Post-operative Nausea
    Postoperative nausea onset (no nausea, immediate, 1st day, 2nd day, 3rd day, 4th day, 5th day, 6th day, 7th day)
    Duration of Post-operative Nausea
    Postoperative nausea duration (no nausea,1 day, 2 days, 3 days, 4 days, if more specify)
    Occurence of Postoperative Vomiting
    Postoperative vomiting occurrence (yes, no)
    Total Number of Post-operative Vomiting Episodes
    Postoperative vomiting number of attacks (no vomiting,1, 2, 3, if more specify)

    Secondary Outcome Measures

    Onset of 1st Post-operative Oral Intake
    feeding onset (1st day i. surgery day, 2nd day, 3rd day)
    Average Amount of Meal Per Day
    adequacy of meals (inadequate, adequate)
    Average Frequency of Meals Per Day
    average frequency of meals (1 meal, 2 meals, if more specify)

    Full Information

    First Posted
    March 21, 2015
    Last Updated
    June 20, 2015
    Sponsor
    King Fahd General Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02401529
    Brief Title
    Effect of Steroids on Post-tonsillectomy Morbidities
    Official Title
    Effect of Steroids on Post-tonsillectomy Morbidities
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2013 (undefined)
    Primary Completion Date
    March 2014 (Actual)
    Study Completion Date
    March 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    King Fahd General Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study aims to evaluate the effect of postoperative systemic rapid onset and short acting dexamethasone followed by a tapering dose of oral prednisolone on post-tonsillectomy morbidities. Half of the patients who comply with the inclusion criteria were selected to receive a single postoperative dose of intravenous dexamethasone followed by oral steroids; the second group received placebo.
    Detailed Description
    The effect of preoperative systemic steroids on post-tonsillectomy morbidities such as pain, nausea, vomiting and delayed feeding was proven. However, this study aims to evaluate the effect of postoperative systemic rapid onset and short acting dexamethasone followed by a tapering dose of oral prednisolone on the aforementioned morbidities and on decreasing the duration and costs of hospital stays. patients who were in the waiting list for tonsillectomy procedure were screened for medical history and those who comply with the inclusion criteria were randomly assigned into two equal groups of 50 patients each. One group was selected to receive a single postoperative dose of intravenous dexamethasone followed by oral steroids; the second group received placebo. Questionnaires investigating postoperative pain, nausea, vomiting, and oral intake were answered by patients, parents or guardians where applicable.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postoperative Pain, Postoperative Nausea and Vomiting
    Keywords
    Dexamethasone, Prednisolone, Tonsillectomy Nausea, Pain, Postoperative, Postoperative Nausea and Vomiting, Randomized controlled trial, Post-tonsillectomy pain, delayed feeding

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    100 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    IV dexamethasone and oral Prednisolone
    Arm Type
    Experimental
    Arm Description
    Single dose of intravenous dexamethasone given immediately following surgery (0.15 mg/kg), followed by oral Prednisolone (0.25mg/kg/day for 7 days then tapering for next 7 days) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).
    Arm Title
    Placebo
    Arm Type
    Active Comparator
    Arm Description
    Placebo (IV saline) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).
    Intervention Type
    Drug
    Intervention Name(s)
    IV dexamethasone
    Other Intervention Name(s)
    Decadron
    Intervention Description
    0.15 mg/kg
    Intervention Type
    Drug
    Intervention Name(s)
    Oral prednisolone
    Other Intervention Name(s)
    Predosone
    Intervention Description
    0.25mg/kg/day for 7 days then tapering for next 7 days
    Intervention Type
    Drug
    Intervention Name(s)
    Paracetamol
    Other Intervention Name(s)
    Adol
    Intervention Description
    acetaminophen 15 mg/kg/dose every 6 hours
    Intervention Type
    Drug
    Intervention Name(s)
    IV saline
    Other Intervention Name(s)
    Saline
    Intervention Description
    IV saline
    Primary Outcome Measure Information:
    Title
    Maximum Severity of Post-operative Pain
    Description
    5 grades (pain free, low disability and low intensity, low disability and high intensity, high disability and moderate intensity, high disability and severly limiting)
    Time Frame
    The severest pain grade felt within a week
    Title
    Duration of Post-operative Pain
    Description
    4 selections (1 day, 2 days, 3 days, if more specify)
    Time Frame
    number of days at which pain was experienced within the the 1st sevn days post -surgery
    Title
    Occurence of Post-operative Nausea
    Description
    Postoperative nausea occurence (yes, no)
    Time Frame
    7 days
    Title
    Onset of Post-operative Nausea
    Description
    Postoperative nausea onset (no nausea, immediate, 1st day, 2nd day, 3rd day, 4th day, 5th day, 6th day, 7th day)
    Time Frame
    onset of 1st ocurence of nausea attack within the 1st week post-surgery
    Title
    Duration of Post-operative Nausea
    Description
    Postoperative nausea duration (no nausea,1 day, 2 days, 3 days, 4 days, if more specify)
    Time Frame
    7 days
    Title
    Occurence of Postoperative Vomiting
    Description
    Postoperative vomiting occurrence (yes, no)
    Time Frame
    7 days
    Title
    Total Number of Post-operative Vomiting Episodes
    Description
    Postoperative vomiting number of attacks (no vomiting,1, 2, 3, if more specify)
    Time Frame
    total number of post-operative vomiting episodes which were experienced within the 1st week post-surgery
    Secondary Outcome Measure Information:
    Title
    Onset of 1st Post-operative Oral Intake
    Description
    feeding onset (1st day i. surgery day, 2nd day, 3rd day)
    Time Frame
    Onset of 1st post-operative oral intake recorded within the 1st 3days post-surgery
    Title
    Average Amount of Meal Per Day
    Description
    adequacy of meals (inadequate, adequate)
    Time Frame
    3 days
    Title
    Average Frequency of Meals Per Day
    Description
    average frequency of meals (1 meal, 2 meals, if more specify)
    Time Frame
    average number of meals consumed per day for the 1st three days post-surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    5 Years
    Maximum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients in the waiting list for tonsillectomy under general anesthesia who accepted to participate in the study. Exclusion Criteria: Patients who are allergic to steroids or those who have medical conditions which contraindicate the use of steroid i.e diabetes mellitus, gastritis, or hypertension and those who were on exogenous steroid supplements.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Dr.Faris A Bahammam, MD
    Organizational Affiliation
    ORL and Head & Neck Surgeon
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
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    12670818
    Citation
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