Protocol summary

Summary
Patients were selected from those admitted in ENT unit of Birjand Vliasr hospital for tonsillectomy and adeno-tonsillectomy. All patients were examined by an ENT specialist before surgery and then referred to anesthesia clinic for pre-operation evaluation. The conditions for participating in the study were explained for all patients or their guardians and a written consent was obtained if they tended to participate. Participants were randomly divided in two experimental and control groups. Patients were hospitalized in ENT one day before operation while their vital signs, history and physical examination were performed by the ENT specialist. In all patients routine pre-operation tests were done including; CBC diff, B&G Rh PT& PTT, nasopharynx and lateral radiographs, and in patients over 40 years ECG and CXR. The night before surgery patients were NPO for at least 8 hours. In control group serum dextrose water %5 was started as maintenance with a dose of 35 mg/kg body weight in adults and 10 mg/kg body weight in children. In experimental group during the first 24 hours, in addition to serum dextrose water %5, the same dose of ampicillin was used. Patients took ampicillin in IV, 75 mg/kg a dose before surgery and then for 24 hours 1 dose every 6 hours. Next they received 50 mg/kg amoxicillin every 6 hours for a week. After surgery patients took serum until they were able to eat. In the recovery patients were examined by a trained but unaware nurse (who didn’t know which group had received antibiotics and which had not) every hour for 4 hours, then every 3 hours in two sessions (up to 10 hours after surgery) and after 24 hours. Bleeding, nausea and vomiting, the start time of drinking liquids, speak status, pain, oral temperature and wound healing were all considered and data was recorded in a questionnaire. Patients were discharged from the hospital after 24 hours and were recommended to refer in any case of complications and intense pain. 7 days after the surgery patients were visited again for evaluation of their improvement and data was recorded. Both groups received washing with cold NS (normal saline) and the same cold liquid diet.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2012120211637N1
Registration date: 2013-02-05, 1391/11/17
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-02-05, 1391/11/17
Registrant information
Name
Seyed Hasan Golboie Mousavi
Name of organization / entity
Birjand Univercity of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 1444 0388
Email address
rezamood@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Birjand Univercity of Medical Sciences-research assistant
Expected recruitment start date
2012-11-20, 1391/08/30
Expected recruitment end date
2013-01-19, 1391/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of antibiotic therapy on recovery after tonsillectomy and adenotonsillectomy complications
Public title
Effect of antibiotic therapy on recovery after tonsillectomy and adenotonsillectomy complications
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criterion: all patients admitted for tonsillectomy and adenotonsillectomy in ear, nose and throat department Valiasr Hospital, Birjand, Iran. Exclusion critria: fever (oral temperature greater than 38.2); acute larengopharngyt or evidence of systemic infection in the past three weeks; adenoidectomy alone any type of bleeding disorder (pt, ptt abnormal) and throat disorders like laryngeal cleft palate with underlying diseases (heart disease, respiratory ...) or contraindication for general anesthesia, history of Perry tonsilar abscess, serous otitis media (SOME), evidence of active infection at the time of entry, immunodeficiency, and long-term use of corticosteroids.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 138
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Birjand Univercity of Medical Sciences Ethics Committee
Street address
Birjand Univercity of Medical Sciences, Ghaffari Street
City
Birjand
Postal code
Approval date
2012-11-11, 1391/08/21
Ethics committee reference number
125/85044

Health conditions studied

1

Description of health condition studied
Tonsillectomy
ICD-10 code
28.92
ICD-10 code description
tonsillectomy

2

Description of health condition studied
Adenotonsillectomy
ICD-10 code
28.92
ICD-10 code description
Adenectomy

Primary outcomes

1

Description
postoperative Recovery and complications
Timepoint
from 4 hours after surgery to one week later
Method of measurement
Nausea and vomiting - oral temperature - bleeding - Time to start drinking fluids - pain -analgesia needed after tonsillectomy and adenotonsillectomy r

Secondary outcomes

1

Description
oral tempreture
Timepoint
4 hours after operation-10 hours after operation-1 week after operation
Method of measurement
mercury thermometer

2

Description
pain
Timepoint
4 hours after surgery-7 hours after surgery-10 hours after surgery-1 week after surgery
Method of measurement
pain scale Criterion

3

Description
nausea-vommiting
Timepoint
6 hours after surgery
Method of measurement
Rhodes index

4

Description
bleeding
Timepoint
intra operation-24 hours after operation-24 hours later
Method of measurement
a case history

5

Description
White blood cell count
Timepoint
24 hours after operation
Method of measurement
CBC

Intervention groups

1

Description
Ampicillin intravenously as a single dose of 75 mg per kg before surgery and one dose every 6 hours to 24 hours one and for one week amoxiciline capsul 50 mg per kg every 8 hours
Category
Treatment - Drugs

2

Description
The control group did not receive any antibiotics.
Category
Diagnosis

Recruitment centers

1

Recruitment center
Name of recruitment center
ENTdepartment, Birjand Valiasr hospital
Full name of responsible person
Dr Golboie, ENT specialist
Street address
Ghaffari street- Valiasr hospital
City
Birjand

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Birjand Univercity of Medical Sciences
Full name of responsible person
Dr Asghar Zarban
Street address
Birjand Univercity of Medical Sciences, Ghaffari street
City
Birgand
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand Univercity 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
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr Mohammadreza Mofateh
Position
ENT specialist
Other areas of specialty/work
Street address
Ghaffari street, Birjand University of Medical Sciences
City
Birjand
Postal code
Phone
+98 56 1444 0388
Fax
Email
rezamood@bums.ac.ir; yaldajannesar@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr Seyed Hasan Golboie Mousavi
Position
ENT specialist
Other areas of specialty/work
Street address
Ghaffari street- Birjand University of Medical Sciences
City
Birjand
Postal code
Phone
+98 56 1444 0388
Fax
Email
dr.golboie@yahoo.com; yaldajannesar@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr Mohammadreza Mofateh
Position
ENTspecialist
Other areas of specialty/work
Street address
Ghaffari street, Birjand University of Medical Sciences
City
Birjand
Postal code
Phone
+98 56 1444 3000
Fax
Email
yaldajannesar@gmail.comrezamood@bums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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