Effect of Steroids on Post-tonsillectomy Morbidities

King Fahd General Hospital

Status and phase: Completed; Phase 2

Conditions: Postoperative Pain; Postoperative Nausea and Vomiting

Treatments: Drug: Paracetamol; Drug: IV saline; Drug: IV dexamethasone; Drug: Oral prednisolone

Study type: Interventional

Funder types: Other

Identifiers

NCT02401529

Bahammam-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 5 to 20 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

IV dexamethasone and oral Prednisolone

Experimental group

Description:

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).

Treatment:

Drug: Oral prednisolone

Drug: IV dexamethasone

Drug: Paracetamol

Placebo

Active Comparator group

Description:

Placebo (IV saline) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).

Treatment:

Drug: IV saline

Drug: Paracetamol