Trial Outcomes & Findings for Effect of Steroids on Post-tonsillectomy Morbidities (NCT NCT02401529)

NCT ID: NCT02401529

Last Updated: 2015-07-15

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 100 participants
• Primary outcome timeframe: The severest pain grade felt within a week
• Results posted on: 2015-07-15

Participant Flow

116 participants were initially considered for the study. However, only 100 were considered in the final results. some were excluded due to not matching inclusion criteria. others failed to attend follow up visits, adhere to treatment protocol or complete the questionnaire as required. Please refer to section ( period 1) for further details.

Participant milestones

Measure	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). IV dexamethasone: 0.15 mg/kg Oral prednisolone: 0.25mg/kg/day for 7 days then tapering for next 7 days Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours	Placebo Placebo (IV saline) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours). Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours IV saline: IV saline
Overall Study STARTED	59	57
Overall Study COMPLETED	50	50
Overall Study NOT COMPLETED	9	7

Reasons for withdrawal

Measure	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). IV dexamethasone: 0.15 mg/kg Oral prednisolone: 0.25mg/kg/day for 7 days then tapering for next 7 days Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours	Placebo Placebo (IV saline) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours). Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours IV saline: IV saline
Overall Study Lost to Follow-up	2	1
Overall Study Physician Decision	2	6
Overall Study Protocol Violation	5	0

Baseline Characteristics

Effect of Steroids on Post-tonsillectomy Morbidities

Baseline characteristics by cohort

Measure	IV Dexamethasone and Oral Prednisolone n=50 Participants 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). IV dexamethasone: 0.15 mg/kg Oral prednisolone: 0.25mg/kg/day for 7 days then tapering for next 7 days Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours	Placebo n=50 Participants Placebo (IV saline) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours). Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours IV saline: IV saline	Total n=100 Participants Total of all reporting groups
Age, Continuous	8.5 years n=5 Participants	8.7 years n=7 Participants	8.6 years n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	21 Participants n=7 Participants	37 Participants n=5 Participants
Sex: Female, Male Male	34 Participants n=5 Participants	29 Participants n=7 Participants	63 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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)

Outcome measures

Measure	IV Dexamethasone and Oral Prednisolone n=50 Participants 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). IV dexamethasone: 0.15 mg/kg Oral prednisolone: 0.25mg/kg/day for 7 days then tapering for next 7 days Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours	Placebo n=50 Participants Placebo (IV saline) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours). Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours IV saline: IV saline
Maximum Severity of Post-operative Pain Low disability and low intensity	37 participants	26 participants
Maximum Severity of Post-operative Pain high disability and moderate intensity	13 participants	21 participants
Maximum Severity of Post-operative Pain high disability and high intensity	0 participants	3 participants

PRIMARY outcome

Timeframe: 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)

Outcome measures

Measure	IV Dexamethasone and Oral Prednisolone n=50 Participants 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). IV dexamethasone: 0.15 mg/kg Oral prednisolone: 0.25mg/kg/day for 7 days then tapering for next 7 days Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours	Placebo n=50 Participants Placebo (IV saline) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours). Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours IV saline: IV saline
Duration of Post-operative Pain one day	36 participants	23 participants
Duration of Post-operative Pain two days	11 participants	19 participants
Duration of Post-operative Pain three days	3 participants	8 participants

PRIMARY outcome

Timeframe: 7 days

Postoperative nausea occurence (yes, no)

Outcome measures

Measure	IV Dexamethasone and Oral Prednisolone n=50 Participants 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). IV dexamethasone: 0.15 mg/kg Oral prednisolone: 0.25mg/kg/day for 7 days then tapering for next 7 days Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours	Placebo n=50 Participants Placebo (IV saline) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours). Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours IV saline: IV saline
Occurence of Post-operative Nausea yes	17 participants	29 participants
Occurence of Post-operative Nausea no	33 participants	21 participants

PRIMARY outcome

Timeframe: 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)

Outcome measures

Measure	IV Dexamethasone and Oral Prednisolone n=50 Participants 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). IV dexamethasone: 0.15 mg/kg Oral prednisolone: 0.25mg/kg/day for 7 days then tapering for next 7 days Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours	Placebo n=50 Participants Placebo (IV saline) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours). Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours IV saline: IV saline
Onset of Post-operative Nausea no nausea	33 participants	21 participants
Onset of Post-operative Nausea immediately	10 participants	8 participants
Onset of Post-operative Nausea 1st day	4 participants	11 participants
Onset of Post-operative Nausea immediately and 1st day	3 participants	10 participants

PRIMARY outcome

Timeframe: 7 days

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

Outcome measures

Measure	IV Dexamethasone and Oral Prednisolone n=50 Participants 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). IV dexamethasone: 0.15 mg/kg Oral prednisolone: 0.25mg/kg/day for 7 days then tapering for next 7 days Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours	Placebo n=50 Participants Placebo (IV saline) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours). Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours IV saline: IV saline
Duration of Post-operative Nausea no nausea	33 participants	21 participants
Duration of Post-operative Nausea one day	3 participants	8 participants
Duration of Post-operative Nausea two days	14 participants	15 participants
Duration of Post-operative Nausea three days	0 participants	6 participants

PRIMARY outcome

Timeframe: 7 days

Postoperative vomiting occurrence (yes, no)

Outcome measures

Measure	IV Dexamethasone and Oral Prednisolone n=50 Participants 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). IV dexamethasone: 0.15 mg/kg Oral prednisolone: 0.25mg/kg/day for 7 days then tapering for next 7 days Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours	Placebo n=50 Participants Placebo (IV saline) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours). Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours IV saline: IV saline
Occurence of Postoperative Vomiting yes	25 participants	36 participants
Occurence of Postoperative Vomiting no	25 participants	14 participants

PRIMARY outcome

Timeframe: 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)

Outcome measures

Measure	IV Dexamethasone and Oral Prednisolone n=50 Participants 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). IV dexamethasone: 0.15 mg/kg Oral prednisolone: 0.25mg/kg/day for 7 days then tapering for next 7 days Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours	Placebo n=50 Participants Placebo (IV saline) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours). Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours IV saline: IV saline
Total Number of Post-operative Vomiting Episodes no vomiting	25 participants	14 participants
Total Number of Post-operative Vomiting Episodes once	13 participants	9 participants
Total Number of Post-operative Vomiting Episodes twice	7 participants	19 participants
Total Number of Post-operative Vomiting Episodes three times	4 participants	8 participants
Total Number of Post-operative Vomiting Episodes more than 3 times	1 participants	0 participants

SECONDARY outcome

Timeframe: 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)

Outcome measures

Measure	IV Dexamethasone and Oral Prednisolone n=50 Participants 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). IV dexamethasone: 0.15 mg/kg Oral prednisolone: 0.25mg/kg/day for 7 days then tapering for next 7 days Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours	Placebo n=50 Participants Placebo (IV saline) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours). Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours IV saline: IV saline
Onset of 1st Post-operative Oral Intake surgery day	46 participants	37 participants
Onset of 1st Post-operative Oral Intake 1st day after surgery	4 participants	13 participants

SECONDARY outcome

Timeframe: 3 days

adequacy of meals (inadequate, adequate)

Outcome measures

Measure	IV Dexamethasone and Oral Prednisolone n=50 Participants 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). IV dexamethasone: 0.15 mg/kg Oral prednisolone: 0.25mg/kg/day for 7 days then tapering for next 7 days Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours	Placebo n=50 Participants Placebo (IV saline) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours). Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours IV saline: IV saline
Average Amount of Meal Per Day inadequate	16 participants	27 participants
Average Amount of Meal Per Day adequate	34 participants	23 participants

SECONDARY outcome

Timeframe: 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)

Outcome measures

Measure	IV Dexamethasone and Oral Prednisolone n=50 Participants 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). IV dexamethasone: 0.15 mg/kg Oral prednisolone: 0.25mg/kg/day for 7 days then tapering for next 7 days Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours	Placebo n=50 Participants Placebo (IV saline) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours). Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours IV saline: IV saline
Average Frequency of Meals Per Day 1 meal	2 participants	1 participants
Average Frequency of Meals Per Day 2 meals	20 participants	34 participants
Average Frequency of Meals Per Day 3 meals	28 participants	15 participants

Adverse Events

IV Dexamethasone and Oral Prednisolone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	IV Dexamethasone and Oral Prednisolone n=50 participants at risk 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). IV dexamethasone: 0.15 mg/kg Oral prednisolone: 0.25mg/kg/day for 7 days then tapering for next 7 days Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours	Placebo n=50 participants at risk Placebo (IV saline) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours). Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours IV saline: IV saline
Surgical and medical procedures Infection	0.00% 0/50	0.00% 0/50
Gastrointestinal disorders Excess stomach acid	0.00% 0/50	0.00% 0/50
Surgical and medical procedures Bleeding	0.00% 0/50	0.00% 0/50

Other adverse events

Adverse event data not reported

Additional Information

Dr Faris Ahmed Bahammam

King Fahd General Hospital

Phone: 00966554699544

Email: dr_farisbahammam@yahoo.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place