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Comparative study of effect of second dose of pregabalin, acetaminophen, naproxen and dextromethorphan on postoperative analgesia

Protocol summary

Study aim
Determination and comparison of the effect of the second dose of the combination of Pregabalin, Acetaminophen, Naproxen and Dextromethorphan on postoperative analgesia
Design
Randomized, double blinded, sham controlled clinical trial 60 Patients are divided into two groups randomly according to the random number table to receive the second dose of agents after transferred to the ward; A group that has an individual number receives a second dose of the non-narcotic drugs combination and the other group (paired numbers) receives the placebo.
Settings and conduct
Evaluation of the severity and type of pain after surgeries: Nephrectomy, Cystetomy, Prostatectomy, Colectomy, Vippel and RPLND in Imam Khomeini Hospital in intervention group (administration of the second dose of non-narcotic drugs combination) and control group (placebo) The drug combination and the placebo will be packed in the same white envelopes as the research guide and will be provided to the prescribes for the second dose
Participants/Inclusion and exclusion criteria
Including criteria: All patients with ASA-PS score of one to three who are on the list of surgeries: Nephrectomy, Cystetomy, Prostatectomy, Colectomy, Vippel and RPLND and aged 18 to 80 years Excluding criteria: Drug addicts History of taking antidepressants and anticonvulsants in the last 6 months Any contraindication or allergy to Pregabalin, Acetaminophen, Naproxen and Dextromethorphan Patients who are not extubated after surgery
Intervention groups
Within 6 hours after Discharge from the recovery, In the intervention group the second dose of PAND is repeated And in the control group placebo is prescribed.
Main outcome variables
Age; Sex; surgery Indication; Type of surgery; Patient’s group; Time of first opioid request; Sum of opioid received; Pain intensity; Complications

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20181219042046N1
Registration date: 2019-04-19, 1398/01/30
Registration timing: prospective

Last update: 2019-04-19, 1398/01/30
Update count: 0
Registration date
2019-04-19, 1398/01/30
Registrant information
Name
Majid Amini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3441 5047
Email address
aminimajid1990@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-21, 1398/02/01
Expected recruitment end date
2019-06-22, 1398/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of effect of second dose of pregabalin, acetaminophen, naproxen and dextromethorphan on postoperative analgesia
Public title
Effect of non-narcotic agents on postoperative analgesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with ASA-PS score of one to three who are on the list of surgeries: Nephrectomy, Cystetomy, Prostatectomy, Colectomy, Vippel and RPLND and aged 18 to 80 years
Exclusion criteria:
Drug addicts Any contraindication and allergy to Pregabalin, Acetaminophen, Naproxen and Dextromethorphan Patients who are not extubated after surgery
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are divided into two groups randomly according to the random number table to receive the second dose after being transferred to the ward; Accordingly, each patient is assigned a random number (individual or paired) randomly. The combination of the drug and the placebo will be packed in the same white envelopes as the research guide and will be provided to the prescribes for the second dose. A group that has an individual number receives a second dose of the drug compound and the other group (paired numbers) receives the placebo. The only person who knows the contents of the envelope is the research guide and the patients, the administrators and outcome evaluator are unaware.
Blinding (investigator's opinion)
Double blinded
Blinding description
The drug combination and the placebo will be packed in the same white envelopes as the research guide and will be provided to the prescribes for the second dose.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Imam Khomaini Hospital Complex, Keshavarz Blvd., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417933791
Approval date
2018-04-18, 1397/01/29
Ethics committee reference number
IR.TUMS.IKHC.REC.1398.017

Health conditions studied

1

Description of health condition studied
Postoperative pain
ICD-10 code
T40.0
ICD-10 code description
Poisoning by, adverse effect of and underdosing of opium

Primary outcomes

1

Description
Pain severity by using UPAT (universal pain assessment tool)
Timepoint
Pain measurement at 0, 2, 4, 6, 8, 12, 24, 48 hours after surgery
Method of measurement
UPAT (universal pain assessment tool)

Secondary outcomes

1

Description
29/5000Type of pain: somatic or neuropathic
Timepoint
Evaluation at times 0, 2, 4, 6, 8, 12, 24 and 48 hours after surgery
Method of measurement
Descriptive history of the patient

Intervention groups

1

Description
Intervention group: Administration of the second dose of the combination of Cap Pregabalin 300mg, Tab Acetaminophen 1g, Tab Naproxen 500mg and Tab Dextromethorphan 30 mg for postoperative analgesia
Category
Treatment - Drugs

2

Description
Control group: Prescribing a placebo instead of a second dose
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam khomaini Hospital Complex
Full name of responsible person
Majid Amini
Street address
Imam Khomaini Hospital Complex, Keshavarz Blvd., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417933791
Phone
+98 31 3441 5047
Email
aminimajid1990@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Ali Sahraeyan
Street address
Imam khomeini Hospital Complex- Keshavarz Blvd - Tehran - Iran
City
Tehran
Province
Tehran
Postal code
1417933791
Phone
+98 31 3441 5047
Email
aminimajid1990@gmail.com
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
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Majid Amini
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Imam khomeini Hospital Complex- Keshavarz Blvd - Tehran - Iran
City
Tehran
Province
Tehran
Postal code
1417933791
Phone
+98 31 3441 5047
Fax
Email
aminimajid1990@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Majid Amini
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Imam khomeini Hospital Complex- Keshavarz Blvd - Tehran - Iran
City
Tehran
Province
Tehran
Postal code
1417933791
Phone
+98 31 3441 5047
Fax
Email
aminimajid1990@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Majid Amini
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Imam khomeini Hospital Complex- Keshavarz Blvd - Tehran - Iran
City
Tehran
Province
Tehran
Postal code
1417933791
Phone
+98 31 3441 5047
Fax
Email
aminimajid1990@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
severity and type pain
When the data will become available and for how long
6 month after outcomes released
To whom data/document is available
academic and scientific persons
Under which criteria data/document could be used
There is no limit to the use of data or documentation due to unidentifiable patient information.
From where data/document is obtainable
Majid Amini aminimajid1990@gmail.com
What processes are involved for a request to access data/document
After receiving an application via email, it will be answered for one week.
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