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
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
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
NCT ID
NCT02401529
First Posted
March 21, 2015
Last Updated
June 20, 2015
Sponsor
King Fahd General Hospital
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
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Effect of Steroids on Post-tonsillectomy Morbidities
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