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Effect of Steroids on Post-tonsillectomy Morbidities

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ClinicalTrials.gov Identifier: NCT02401529
Recruitment Status : Completed
First Posted : March 30, 2015
Results First Posted : July 15, 2015
Last Update Posted : July 15, 2015
Sponsor:
Information provided by (Responsible Party):
Dr Faris Bahammam, King Fahd General Hospital

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.

Condition or disease Intervention/treatment Phase
Postoperative Pain Postoperative Nausea and Vomiting Drug: IV dexamethasone Drug: Oral prednisolone Drug: Paracetamol Drug: IV saline Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Effect of Steroids on Post-tonsillectomy Morbidities
Study Start Date : January 2013
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine


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 Name: Decadron

Drug: Oral prednisolone
0.25mg/kg/day for 7 days then tapering for next 7 days
Other Name: Predosone

Drug: Paracetamol
acetaminophen 15 mg/kg/dose every 6 hours
Other Name: 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 Name: Adol

Drug: IV saline
IV saline
Other Name: Saline




Primary Outcome Measures :
  1. 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)

  2. 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)

  3. Occurence of Post-operative Nausea [ Time Frame: 7 days ]
    Postoperative nausea occurence (yes, no)

  4. 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)

  5. 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)

  6. Occurence of Postoperative Vomiting [ Time Frame: 7 days ]
    Postoperative vomiting occurrence (yes, no)

  7. 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)


Secondary Outcome Measures :
  1. 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)

  2. Average Amount of Meal Per Day [ Time Frame: 3 days ]
    adequacy of meals (inadequate, adequate)

  3. 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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   5 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02401529


Sponsors and Collaborators
King Fahd General Hospital
Investigators
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Principal Investigator: Dr.Faris A Bahammam, MD ORL and Head & Neck Surgeon

Publications:

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Responsible Party: Dr Faris Bahammam, Dr, King Fahd General Hospital
ClinicalTrials.gov Identifier: NCT02401529    
Other Study ID Numbers: Bahammam-1
First Posted: March 30, 2015    Key Record Dates
Results First Posted: July 15, 2015
Last Update Posted: July 15, 2015
Last Verified: June 2015
Keywords provided by Dr Faris Bahammam, King Fahd General Hospital:
Dexamethasone
Prednisolone
Tonsillectomy Nausea
Pain, Postoperative
Postoperative Nausea and Vomiting
Randomized controlled trial
Post-tonsillectomy pain
delayed feeding
Additional relevant MeSH terms:
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Nausea
Vomiting
Postoperative Nausea and Vomiting
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Signs and Symptoms, Digestive
Acetaminophen
Dexamethasone
Dexamethasone acetate
Prednisolone
Methylprednisolone Acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors