Objectives: evaluation of the effect of preemptive intravenous dexamethasone on post-tonsillectomy pain.
Design: a randomized triple blind study.
Setting and conduct: evaluation of pain 1, 4, 10, and 24 hours after surgery with Faces Pain Scale Questionnaire.
Major inclusion criteria: all patients with chronic tonsillitis (with or without caseoum) with obstructive symptoms; without response to medical therapy who are candidate for adenotonsillectomy.
Major exclusion criteria: allergy to dexamethasone; coagulative disorders; non cooperative patients (cerebral palsy,...) or parents; post op bleeding that needs control in OR.
Intervention:
1) Intervention group: Iv dexamethasone (Alborz daru Co.) 0.1 mg/kg 1 hour before surgery.
2) Control group: IV distilled water 1 hour before surgery.
main outcome measures (variables): evaluation of post tonsillectomy pain at first post op 24 hours.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015112024852N2
Registration date:2016-08-28, 1395/06/07
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-08-28, 1395/06/07
Registrant information
Name
Ruhollah Abbasi
Name of organization / entity
Hamedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3252 0182
Email address
r.abbasi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Hamedan university of medical sciences.
Expected recruitment start date
2015-12-31, 1394/10/10
Expected recruitment end date
2016-06-30, 1395/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of preemptive intravenous dexamethasone on post-tonsillectomy pain, a randomized triple blind study.
Public title
Reduction of post tonsillectomy pain.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
all patients with chronic tonsillitis (with or without caseoum) with obstructive symptoms; without response to medical therapy who are candidate for adenotonsillectomy.
Exclusion criteria:
allergy to dexamethasone; coagulative disorders; non cooperative patients (cerebral palsy,...) or parents; post op bleeding that needs control in OR.
Age
From 5 years old to 15 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
randomization: block randomization
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hamedan university of medical sciences
Street address
Shahid Fahmideh avenue, Hamedan
City
Hamedan
Postal code
Approval date
2015-10-17, 1394/07/25
Ethics committee reference number
IR.UMSHA.REC.1394.328
Health conditions studied
1
Description of health condition studied
post tonsillectomy pain
ICD-10 code
J35.0, J35
ICD-10 code description
Chronic tonsillitis, Hypertrophy of tonsils with hypertrophy of adenoids.
Primary outcomes
1
Description
Evaluation of post tonsillectomy pain at first post op 24 hours.