Objective of this study is to evaluate the effect of Co-Amoxiclave on post-adenotonsillectomy pain and bleeding. A randomized double blind stage III clinical trial with placebo (control group) in a single center (Shiraz Dastgheib Hospital) will be conducted from February 2012 to February 2014. Oral dosage of 5ml CO-Amoxiclave suspention 457, 312 and 156 in adults and children more than 6 years and children with 3-6 years old, respectively every 8 hours will be administered. The duration of intervention will be one week after surgery.
Indication of tonsillectomy in our study will be three or more severe recurrent attacks of tonsillitis within each two consecutive years.
Exclusion criteria are:
1- Medical condition requiring pre-operative antibiotics.
2-Antibiotics administered within 1 weak prior to tonsillectomy.
3- History of penicillin allergy.
4- Children less than 3 years old.
We will have 150 patients, in two groups (oral antibiotic and placebo). The placebo made by the local pharmacy in Dastgheib Hospital for control group. We consider pain and hemorrhage as the primary outcome, also return time to normal diet, Acetaminophen consumption and fever as secondary outcome. To evaluate post-operative pain, we use Visual analog scale. The attacks of post-tonsillectomy hemorrhage will consider positive when patients refer to hospital and check by ENT specialist. Outcomes will check for seven days after operation. Pain and temperature will be checked four times a day; before breakfast, lunch, dinner and before sleep.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014010715496N2
Registration date:2014-01-29, 1392/11/09
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-01-29, 1392/11/09
Registrant information
Name
Sareh Roosta
Name of organization / entity
Vice Chancellor for Research and Technology, Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3612 5323
Email address
namazi_balini@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shiraz University of Medical Sciences
Expected recruitment start date
2012-02-01, 1390/11/12
Expected recruitment end date
2014-02-28, 1392/12/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Co-Amoxiclave on post-adenotonsillectomy pain and bleeding
Public title
The effect of Co-Amoxiclave on post-adenotonsillectomy pain and bleeding
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: patients who undergo tonsillectomy. Indication of tonsillectomy is three or more severe recurrent attacks of tonsillitis within each two consecutive years.
Exclusion criteria: medical condition requiring perioperative antibiotics; antibiotics administered within 1 weak prior to tonsillectomy; history of penicillin allergy; children less than 3 years old.
Age
From 3 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences, Zand Street
City
Shiraz
Postal code
Approval date
2007-10-14, 1386/07/22
Ethics committee reference number
CT-86-3653
Health conditions studied
1
Description of health condition studied
Post-adenotonsillectomy pain and bleeding
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Post-adenotonsillectomy pain
Timepoint
0.5, 1, 2, 4, 8, 16, 24 Hours after adenotonsillectomy and then four times a day; before breakfast, lunch, dinner and also before sleep for 7 days after surgery
Method of measurement
Visual Analog Scale (VAS)
2
Description
Post-adenotonsillectomy hemorrhage
Timepoint
Primary hemorrhage: hemorrhage before 24 hours after operation and secondary hemorrhage: after 24 hours after operation
Method of measurement
Observation by ENT specialist
Secondary outcomes
1
Description
Time to return to the normal diet
Timepoint
Seven days after adenotonsillectomy
Method of measurement
Questionnaire that fills by the patients or their parents
2
Description
Acetaminophen consumption
Timepoint
Seven days after adenotonsillectomy
Method of measurement
Questionnaire that fills by the patients or their parents
3
Description
Fever
Timepoint
Seven days after adenotonsillectomy
Method of measurement
The temperature measured by a nurse at the first 24 hour after surgery and by the educated patients or their parents at 2-7 days after operation that records in the questionnaire.
Intervention groups
1
Description
In intervention group: oral dosage of 5ml CO-Amoxiclave suspention 457 (Amoxicillin 400 mg + Clavulanic Acid 57 mg/5 ml) every 8 hours in adults, 5ml CO-Amoxiclave suspention 312(Amoxicillin 250 mg + Clavulanic Acid 62.5 mg/5 ml) every 8 hours in children more than 6 years old ,and 5ml CO-Amoxiclave suspention 156 (Amoxicillin 125 mg + Clavulanic Acid 31.25 mg/5 ml) , in children with 3-6 years old every 8 hours will be administerd for one week after tonsillectomy.
Category
Prevention
2
Description
Control group:
will receive placebo made by the local pharmacy in Dastgheib Hospital for one week after tonsillectomy. .
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Dastgheib hospital
Full name of responsible person
Street address
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, shiraz University of Medical Sciences
Full name of responsible person
Dr. Gholamreza Hatam
Street address
Shiraz University of Medical Sciences, Zand Street
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Otolaryngology, Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Faramarzi
Position
Associate professor of otolaryngology
Other areas of specialty/work
Street address
Khalili Street-Khalili hospital-Department of Otolaryngology
City
Shiraz
Postal code
Phone
+98 71 1629 1478
Fax
Email
Faramarzi@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Center for Development of Clinical Studies of Nemazee hospital- Vice Chancellery of Research and Tec
Full name of responsible person
Sareh Roosta
Position
MSc of biostatistics
Other areas of specialty/work
Street address
Center for Development of Clinical Research of Nemazee Hospital, Nemazee Square, Shiraz
City
Shiraz
Postal code
Phone
+98 71 1612 5323
Fax
Email
namazi_balini@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)