Phase 2
N=116
Effect of Steroids on Post-tonsillectomy Morbidities
Postoperative Pain · Postoperative Nausea and Vomiting
Bottom Line
View on ClinicalTrials.gov: NCT02401529 ↗Enrolled (actual)
116
Serious AEs
0.0%
Results posted
Jul 2015
Primary outcome: Primary: Maximum Severity of Post-operative Pain — 37; 26; 13; 21 participants — p=0.033
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- IV dexamethasone (Drug); Oral prednisolone (Drug); Paracetamol (Drug); IV saline (Drug)
- Age
- Pediatric, Adult · 5+ yrs
- Sex
- All
- Sponsor
- King Fahd General Hospital
- Primary completion
- Mar 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Severity of Post-operative Pain |
37; 26; 13; 21; 0; 3 | 0.033 sig |
| PRIMARY Duration of Post-operative Pain |
36; 23; 11; 19; 3; 8 | 0.026 sig |
| PRIMARY Occurence of Post-operative Nausea |
17; 29; 33; 21 | 0.016 sig |
| PRIMARY Onset of Post-operative Nausea |
33; 21; 10; 8; 4; 11 | 0.019 sig |
| PRIMARY Duration of Post-operative Nausea |
33; 21; 3; 8; 14; 15 | 0.012 sig |
| PRIMARY Occurence of Postoperative Vomiting |
25; 36; 25; 14 | 0.024 sig |
| PRIMARY Total Number of Post-operative Vomiting Episodes |
25; 14; 13; 9; 7; 19 | 0.02 sig |
| SECONDARY Onset of 1st Post-operative Oral Intake |
46; 37; 4; 13 | 0.017 sig |
| SECONDARY Average Amount of Meal Per Day |
16; 27; 34; 23 | 0.026 sig |
| SECONDARY Average Frequency of Meals Per Day |
2; 1; 20; 34; 28; 15 | 0.019 sig |
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.
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.
Data sourced from ClinicalTrials.gov (NCT02401529). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.