Protocol summary

Study aim
Evaluation of the analgesic effect of oral administration of Acetaminophen + Oxycodone after extracorporeal shock with shock waves
Design
A clinical trial with two groups of patients: parallel, therapeutic, blanced block randomization, single blind (patient). 150 patients referred to Sinai Hospital.
Settings and conduct
150 patients at Sina Hospital. blanced block randomization, single blind(patient). Patients are divided into two groups: Group 1: Acetaminophen 325 + oxycodone 5 + diclofenac suppository (100 mg). Group 2 : Diclofenac suppository (100 mg) + placebo.
Participants/Inclusion and exclusion criteria
Inclusion criteria: ASA≤II, Consent to participate in the study, Kidney stones between 4 and 20 mm, No history of previous open surgery, No history of previous crusher. Exclusion criteria: Increased serum creatinine (more than 2 mg/dL), Urinary tract infection, High grade hydronephrosis, Diabetic, Taking NSAIDs, acetaminophen and acetaminophen codeine in the previous 24 hours History of peptic ulcer, Taking peptic ulcer pills, G6PD deficiency, History of liver and kidney disease, History of drug allergy, drug addiction.
Intervention groups
Intervention group 1: Acetaminophen 325 + oxycodone 5 + diclofenac suppository (100 mg) . Intervention group 2: Diclofenac suppository (100 mg) + placebo.
Main outcome variables
Pain control, Complications, hospitalization time, surgical time, and success rate of complete stone therapy.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190624043991N18
Registration date: 2022-09-28, 1401/07/06
Registration timing: prospective

Last update: 2022-09-28, 1401/07/06
Update count: 0
Registration date
2022-09-28, 1401/07/06
Registrant information
Name
Seyed Mohammad Kazem Aghamir
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6634 8560
Email address
mkaghamir@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-11, 1401/08/20
Expected recruitment end date
2023-10-12, 1402/07/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the analgesic effect of oral administration of Acetaminophen + Oxycodone after extracorporeal shock with shock waves
Public title
Evaluation of the analgesic effect after extracorporeal shock with shock waves
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
ASA≤II Consent to participate in the study Kidney stones between 4 and 20 mm No history of previous open surgery No history of previous crusher
Exclusion criteria:
Increased serum creatinine (more than 2 mg/dL) Urinary tract infection High grade hydronephrosis Diabetic Taking NSAIDs, acetaminophen and acetaminophen codeine in the previous 24 hours History of peptic ulcer Taking peptic ulcer pills G6PD deficiency History of liver and kidney disease History of drug allergy drug addiction
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 150
Randomization (investigator's opinion)
Randomized
Randomization description
The present study is a Single blind randomized clinical trial. For randomization, the balanced block randomization method with blocks of size 4 is used. Intervention group A and control group B have been determined. After the methodologist prepares the randomization sequence using the sealdenvelop online site, the generated sequence will be made available to a technician outside the research team. Quadruple blocks (A or B) are placed inside the envelopes. After the arrival of the first patient with the inclusion criteria, the envelopes are randomly selected and the type of patient group is informed to the research team through a trained technician. The patient is placed in (acetaminophen 325 + oxycodone 5 + diclofenac suppository (100 mg)) or (placebo + diclofenac suppository (100 mg))group based on the randomly selected envelope.
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients who have expressed their consent to participate in the study after surgery without knowing the existence of two drug groups based on a randomly selected envelope are placed in the treatment group (acetaminophen 325 + oxycodone 5 + diclofenac suppository (100 mg)) or Placebo + diclofenac suppository (100 mg).
Placebo
Used
Assignment
Parallel
Other design features
-

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee for Research in Tehran University of Medical Sciences
Street address
Room 604, Sixth Floor, medical University Tehran, Central Staff Building, Keshavarz Blvd., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2022-05-30, 1401/03/09
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1401.191

Health conditions studied

1

Description of health condition studied
Urethral stone
ICD-10 code
N21
ICD-10 code description
Calculus of lower urinary tract

Primary outcomes

1

Description
Pain control
Timepoint
Immediately, half an hour and a week after extracorporeal shock with shock waves
Method of measurement
Visual analogue scale questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Acetaminophen 325 + oxycodone 5 + diclofenac suppository (100 mg)
Category
Treatment - Drugs

2

Description
Intervention group: Diclofenac suppository (100 mg) + placebo
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Dr Mohammad Kazem Aghamir
Street address
Urology Research Center, Sina Hospital, Imam Khomeini St., Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8500
Fax
+98 21 6634 8553
Email
mkaghamir@tums.ac.ir
Web page address
http://urc.tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Akbar Fotouhi
Street address
Sixth Floor, medical University Tehran, Central Staff Building, Keshavarz Blvd., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3685
Fax
+98 21 8163 3686
Email
vcr@tums.ac.ir
Web page address
http://vcr.tums.ac.ir/
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
Public
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
Dr Akram Mirzaei
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Medical Biology
Street address
Urology Research Center- Sina Hospital - Imam Khomeini St
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8560
Fax
+98 21 6634 8561
Email
mirzaee.scholar@gmail.com
Web page address
https://URC@tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Mohammad Kazem Aghamir
Position
Head of Urology Research Center
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Urology Research Center- Sina Hospital - Imam Khomeini St
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8560
Fax
+98 21 6634 8561
Email
mkaghamir@tums.ac.ir
Web page address
http://urc.tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Akram Mirzaei
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Medical Biology
Street address
Urology Research Center- Sina Hospital - Imam Khomeini St
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8560
Fax
+98 21 6634 8561
Email
mirzaee.scholar@gmail.com
Web page address
https://URC@tums.ac.ir

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
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
demographic information anonymously
When the data will become available and for how long
one year after publication
To whom data/document is available
Researchers working in academia, physicians, surgeons and hospitals
Under which criteria data/document could be used
Any analysis can be done with the consent of the main researcher
From where data/document is obtainable
Sina Hospital, Urology Research Center, Head of Urology Research Center: Dr. Seyed Mohammad Kazem Aghamir 00982166348560
What processes are involved for a request to access data/document
After reviewing the information by the administrator and epidemiologist, the patient information will be available for the applicant by the provision of a patient's privacy.
Comments
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