Official Title

Effect of Steroids on Post-tonsillectomy Morbidities
  • Phase

    Phase 2
  • Study Type

    Interventional
  • Study Participants

    100
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.
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 Started
Jan 31
2013
Primary Completion
Mar 31
2014
Study Completion
Mar 31
2014
Results Posted
Jul 15
2015
Estimate
Last Update
Jul 15
2015
Estimate

Drug IV saline

IV saline

  • Other names: Saline

Drug IV dexamethasone

0.15 mg/kg

  • Other names: Decadron

Drug Oral prednisolone

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

  • Other names: Predosone

Drug Paracetamol

acetaminophen 15 mg/kg/dose every 6 hours

  • Other names: Adol

IV dexamethasone and oral Prednisolone Experimental

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).

Placebo Active Comparator

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

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.

Summary

IV Dexamethasone and Oral Prednisolone

Placebo

All Events

Event Type Organ System Event Term IV Dexamethasone and Oral Prednisolone Placebo

Maximum Severity of Post-operative Pain

5 grades (pain free, low disability and low intensity, low disability and high intensity, high disability and moderate intensity, high disability and severly limiting)

IV Dexamethasone and Oral Prednisolone

high disability and high intensity

high disability and moderate intensity

13.0
participants

Low disability and low intensity

37.0
participants

Placebo

high disability and high intensity

3.0
participants

high disability and moderate intensity

21.0
participants

Low disability and low intensity

26.0
participants

Duration of Post-operative Pain

4 selections (1 day, 2 days, 3 days, if more specify)

IV Dexamethasone and Oral Prednisolone

one day

36.0
participants

three days

3.0
participants

two days

11.0
participants

Placebo

one day

23.0
participants

three days

8.0
participants

two days

19.0
participants

Occurence of Post-operative Nausea

Postoperative nausea occurence (yes, no)

IV Dexamethasone and Oral Prednisolone

no

33.0
participants

yes

17.0
participants

Placebo

no

21.0
participants

yes

29.0
participants

Onset of Post-operative Nausea

Postoperative nausea onset (no nausea, immediate, 1st day, 2nd day, 3rd day, 4th day, 5th day, 6th day, 7th day)

IV Dexamethasone and Oral Prednisolone

1st day

4.0
participants

immediately

10.0
participants

immediately and 1st day

3.0
participants

no nausea

33.0
participants

Placebo

1st day

11.0
participants

immediately

8.0
participants

immediately and 1st day

10.0
participants

no nausea

21.0
participants

Duration of Post-operative Nausea

Postoperative nausea duration (no nausea,1 day, 2 days, 3 days, 4 days, if more specify)

IV Dexamethasone and Oral Prednisolone

no nausea

33.0
participants

one day

3.0
participants

three days

two days

14.0
participants

Placebo

no nausea

21.0
participants

one day

8.0
participants

three days

6.0
participants

two days

15.0
participants

Occurence of Postoperative Vomiting

Postoperative vomiting occurrence (yes, no)

IV Dexamethasone and Oral Prednisolone

no

25.0
participants

yes

25.0
participants

Placebo

no

14.0
participants

yes

36.0
participants

Total Number of Post-operative Vomiting Episodes

Postoperative vomiting number of attacks (no vomiting,1, 2, 3, if more specify)

IV Dexamethasone and Oral Prednisolone

more than 3 times

1.0
participants

no vomiting

25.0
participants

once

13.0
participants

three times

4.0
participants

twice

7.0
participants

Placebo

more than 3 times

no vomiting

14.0
participants

once

9.0
participants

three times

8.0
participants

twice

19.0
participants

Onset of 1st Post-operative Oral Intake

feeding onset (1st day i. surgery day, 2nd day, 3rd day)

IV Dexamethasone and Oral Prednisolone

1st day after surgery

4.0
participants

surgery day

46.0
participants

Placebo

1st day after surgery

13.0
participants

surgery day

37.0
participants

Average Amount of Meal Per Day

adequacy of meals (inadequate, adequate)

IV Dexamethasone and Oral Prednisolone

adequate

34.0
participants

inadequate

16.0
participants

Placebo

adequate

23.0
participants

inadequate

27.0
participants

Average Frequency of Meals Per Day

average frequency of meals (1 meal, 2 meals, if more specify)

IV Dexamethasone and Oral Prednisolone

1 meal

2.0
participants

2 meals

20.0
participants

3 meals

28.0
participants

Placebo

1 meal

1.0
participants

2 meals

34.0
participants

3 meals

15.0
participants

Total

100
Participants

Age, Continuous

8.6
years (Mean)
Full Range: 5.0 to 19.0

Sex: Female, Male

Overall Study

IV Dexamethasone and Oral Prednisolone

Placebo

Drop/Withdrawal Reasons

IV Dexamethasone and Oral Prednisolone

Placebo