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Evaluation of the effectiveness of preemptive analgesia in combination of Pregabalin, Acetaminophen, Naproxin, Dextrometorhan in Radical neck dissection in Cancer institue of Imam khomeini Hospital

Protocol summary

Summary
A double blind randomized clinical trial, in head and neck surgeries, has been designed to evaluate the preemptive analgesia efficacy of combination of Pregabalin, Naproxin, Acetaminophen and Dextrometorphan to reduce the post operative pain and opioid consumption. Inclusion criteria: patients aged 18-60 years old; ASAps I; candidated for radical neck dissection surgery. Exclusion criteria: history of addiction; ASAps II and more; A drug history of anti convulsant and anti depression; history of gastrointestinal problem and chronic neck pain before surgery. Method: Patients had been devided in two groups, each 40 randomly by age, sex and weight. The case group recieved the combination of Pregabalin, Naproxin, Acetaminophen, dextrometorphan orally, 1 hour before surgery, which dosage according to the weight. For all patients in both groups, the same anesthetic procdure has been used. After finishing the surgury, when the patients has been transfered to recovery then surgery ward, the pain score, the firt time that patients need analgesia and the total dose of morphine in 24 hours has been evaluated and compared between two groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015011620676N1
Registration date: 2016-03-19, 1394/12/29
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-03-19, 1394/12/29
Registrant information
Name
Farhad Tavakoli
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2226 9950
Email address
ftavakoli@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2013-03-21, 1392/01/01
Expected recruitment end date
2014-03-21, 1393/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of preemptive analgesia in combination of Pregabalin, Acetaminophen, Naproxin, Dextrometorhan in Radical neck dissection in Cancer institue of Imam khomeini Hospital
Public title
Evaluation of the effectiveness of preemptive analgesia in Combination of Pregabalin, Acetaminophen, Naproxin, Dextrometorhan in Radical neck dissection
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: patients aged 18-60 years old; ASAps I; candidated for radical neck dissection surgery. Exclusion criteria:ASAps II and more; History of addiction; Drug history for: anti convulsant, anti depression; History of gastrointestinal problem; chronic neck pain before surgery.
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
6th floor, Tehran University of Medical Sciences, Ghods st. Keshavarz blvd.
City
Tehran
Postal code
Approval date
2014-11-25, 1393/09/04
Ethics committee reference number
130/2171/ص/93

Health conditions studied

1

Description of health condition studied
Postoperative pain
ICD-10 code
R52.0
ICD-10 code description
Acute pain

Primary outcomes

1

Description
Pain score
Timepoint
At the interance to ward and after 2, 4, 6, 8, 12, 24 hours
Method of measurement
Universal Pain Assessment Tools (UPAT)

Secondary outcomes

1

Description
Total dose of morphine during 24 hours
Timepoint
At the end of 24 hours
Method of measurement
Patient's medical records

Intervention groups

1

Description
to interventional group: pregabalin (2.5 mg/kg) dextrometorphan (0.3 mg/kg) Naproxin( 7mg/kg), acetaminophen (15mg/kg) orally 1 hour before surgery.
Category
Prevention

2

Description
The control group was not received the combination medicines
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
cancer Institute, Imam Khomeini Hospital
Full name of responsible person
Farhad Tavakoli M.D.
Street address
Operation Rooms of the Cancer Institute Building, Imam Khomeini Hospital, Keshavarz blvd.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shahin Akhond zadeh M.D
Street address
Head center , Keshavarz Blv.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Farhad Tavakoli
Position
MD, Anesthesia residency
Other areas of specialty/work
Street address
Anesthesia Department, KImam homeini Hospital, Keshavarz blvd.
City
Tehran
Postal code
Phone
+98 21 6119 2828
Fax
Email
fahatv@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Farhad Tavakoli M.D.
Position
MD, Anesthesiologist
Other areas of specialty/work
Street address
Anesthesia Department, Imam Khomeini Hospital, Keshavarz blvd.
City
Tehran
Postal code
Phone
+98 21 6119 2828
Fax
Email
fahatv@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Farhad Tavakoli M.D
Position
MD, Anesthesiologist
Other areas of specialty/work
Street address
Anesthesiology Department, Imam Khomeini Hospital, Keshavarz blvd.
City
Tehran
Postal code
Phone
+98 21 6119 2828
Fax
Email
fahatv@yahoo.com
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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