Effect of Steroids on Post-tonsillectomy Morbidities
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| ClinicalTrials.gov Identifier: NCT02401529 |
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Recruitment Status :
Completed
First Posted : March 30, 2015
Results First Posted : July 15, 2015
Last Update Posted : July 15, 2015
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Sponsor:
King Fahd General Hospital
Information provided by (Responsible Party):
Dr Faris Bahammam, King Fahd General Hospital
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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 |
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 (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 |
|---|---|
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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).
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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 |
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Active Comparator: Placebo
Placebo (IV saline) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).
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Drug: Paracetamol
acetaminophen 15 mg/kg/dose every 6 hours
Other Name: Adol Drug: IV saline IV saline
Other Name: Saline |
Primary Outcome Measures :
- 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)
- 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)
- Occurence of Post-operative Nausea [ Time Frame: 7 days ]Postoperative nausea occurence (yes, no)
- 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)
- 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)
- Occurence of Postoperative Vomiting [ Time Frame: 7 days ]Postoperative vomiting occurrence (yes, no)
- 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 :
- 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)
- Average Amount of Meal Per Day [ Time Frame: 3 days ]adequacy of meals (inadequate, adequate)
- 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)
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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
| Principal Investigator: | Dr.Faris A Bahammam, MD | ORL and Head & Neck Surgeon |
Publications:
| 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:
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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, Digestive Acetaminophen Dexamethasone Prednisolone 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 Analgesics, Non-Narcotic Analgesics Sensory System Agents Antipyretics |