Trial Outcomes & Findings for Evaluating Perioperative Dexamethasone and the Risk of Bleeding in Tonsillectomy (NCT NCT01415583)

NCT ID: NCT01415583

Last Updated: 2017-07-12

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 314 participants
• Primary outcome timeframe: 2 weeks after surgery
• Results posted on: 2017-07-12

Participant Flow

Participant milestones

Measure	Saline Dexamethasone: 0.5mg/kg (max dose 20mg)	Dexamethasone Dexamethasone: 0.5mg/kg (max dose 20mg)
Overall Study STARTED	157	157
Overall Study COMPLETED	157	157
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluating Perioperative Dexamethasone and the Risk of Bleeding in Tonsillectomy

Baseline characteristics by cohort

Measure	Saline n=157 Participants Dexamethasone: 0.5mg/kg (max dose 20mg)	Dexamethasone n=157 Participants Dexamethasone: 0.5mg/kg (max dose 20mg)	Total n=314 Participants Total of all reporting groups
Age, Continuous	6 years n=5 Participants	6 years n=7 Participants	6 years n=5 Participants
Sex: Female, Male Female	69 Participants n=5 Participants	75 Participants n=7 Participants	144 Participants n=5 Participants
Sex: Female, Male Male	88 Participants n=5 Participants	82 Participants n=7 Participants	170 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 weeks after surgery

Outcome measures

Measure	Saline n=157 Participants Dexamethasone: 0.5mg/kg (max dose 20mg)	Dexamethasone n=157 Participants Dexamethasone: 0.5mg/kg (max dose 20mg)
Number of Participants With Post-tonsillectomy Bleeding	13 participants Interval 10.4 to 15.6	17 participants Interval 14.4 to 19.6

Adverse Events

Saline

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Dexamethasone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Christopher Hartnick, Division Director, Pediatric Otolaryngology Director, Pediatric Airway, V

Massachusetts Eye and Ear Infirmary

Phone: 617-573-4206

Email: christopher_hartnick@meei.harvard.edu

Results disclosure agreements

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