Effect of Steroids on Post-tonsillectomy Morbidities

June 20, 2015 updated by: Dr Faris Bahammam, King Fahd General Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 20 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IV dexamethasone and oral Prednisolone
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).
Drug: IV dexamethasone
0.15 mg/kg
Other Names:
  • Decadron
Drug: Oral prednisolone
0.25mg/kg/day for 7 days then tapering for next 7 days
Other Names:
  • Predosone
Drug: Paracetamol
acetaminophen 15 mg/kg/dose every 6 hours
Other Names:
  • Adol
Active Comparator: Placebo
Placebo (IV saline) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).
Drug: Paracetamol
acetaminophen 15 mg/kg/dose every 6 hours
Other Names:
  • Adol
Drug: IV saline
IV saline
Other Names:
  • Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum Severity of Post-operative Pain
Time Frame: The severest pain grade felt within a week
5 grades (pain free, low disability and low intensity, low disability and high intensity, high disability and moderate intensity, high disability and severly limiting)
The severest pain grade felt within a week
Duration of Post-operative Pain
Time Frame: number of days at which pain was experienced within the the 1st sevn days post -surgery
4 selections (1 day, 2 days, 3 days, if more specify)
number of days at which pain was experienced within the the 1st sevn days post -surgery
Occurence of Post-operative Nausea
Time Frame: 7 days
Postoperative nausea occurence (yes, no)
7 days
Onset of Post-operative Nausea
Time Frame: onset of 1st ocurence of nausea attack within the 1st week post-surgery
Postoperative nausea onset (no nausea, immediate, 1st day, 2nd day, 3rd day, 4th day, 5th day, 6th day, 7th day)
onset of 1st ocurence of nausea attack within the 1st week post-surgery
Duration of Post-operative Nausea
Time Frame: 7 days
Postoperative nausea duration (no nausea,1 day, 2 days, 3 days, 4 days, if more specify)
7 days
Occurence of Postoperative Vomiting
Time Frame: 7 days
Postoperative vomiting occurrence (yes, no)
7 days
Total Number of Post-operative Vomiting Episodes
Time Frame: total number of post-operative vomiting episodes which were experienced within the 1st week post-surgery
Postoperative vomiting number of attacks (no vomiting,1, 2, 3, if more specify)
total number of post-operative vomiting episodes which were experienced within the 1st week post-surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Onset of 1st Post-operative Oral Intake
Time Frame: Onset of 1st post-operative oral intake recorded within the 1st 3days post-surgery
feeding onset (1st day i. surgery day, 2nd day, 3rd day)
Onset of 1st post-operative oral intake recorded within the 1st 3days post-surgery
Average Amount of Meal Per Day
Time Frame: 3 days
adequacy of meals (inadequate, adequate)
3 days
Average Frequency of Meals Per Day
Time Frame: average number of meals consumed per day for the 1st three days post-surgery
average frequency of meals (1 meal, 2 meals, if more specify)
average number of meals consumed per day for the 1st three days post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King Fahd General Hospital

Investigators

  • Principal Investigator: Dr.Faris A Bahammam, MD, ORL and Head & Neck Surgeon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

March 21, 2015

First Submitted That Met QC Criteria

March 27, 2015

First Posted (Estimate)

March 30, 2015

Study Record Updates

Last Update Posted (Estimate)

July 15, 2015

Last Update Submitted That Met QC Criteria

June 20, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Bahammam-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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