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NCT Number: NCT02401529

Effect of Steroids on Post-tonsillectomy Morbidities

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.

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Key information

Conditions

Postoperative Pain Nausea Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Nausea and Vomiting Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

5 year–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

iv dexamethasone

Drug

0.15 mg/kg

Other names: Decadron

Oral prednisolone

Drug

0.25mg/kg/day for 7 days then tapering for next 7 days

Other names: Predosone

Paracetamol

Drug

acetaminophen 15 mg/kg/dose every 6 hours

Other names: Adol

IV Saline

Drug

IV saline

Other names: Saline

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

King Fahd General Hospital

Other Gov

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Mar 30, 2015
Registry last updated
Jul 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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