The efficacy of oral pain relief Combination analgesic drugs during panretinal photocoagulation for diabetic retinopathy , Pain sensation was evaluated with Visual Analogue Scale (VAS), Changes in blood pressure and pulse
Design
The clinical trial has a control group with cross over, double-blind, randomized groups using randomization table, phase 2-3 on 30 patients.
Settings and conduct
Motahari clinic is located in Shiraz University of Medical Sciences. We divide each patient into four parts (ST/SN/IT/IN) and in each session one area of each eye of the patient is lasered, for example: the patient receives novafen capsule alone in the first session, in the second session, pregabalin capsule and in the third session he receives two drugs and in the fourth session he receives placebo.
Participants/Inclusion and exclusion criteria
age: years old bilateral proliferative diabetic retinopathy or severe non-proliferative diabetic retinopathy no previous laser treatment best corrected visual acuity of 20/200 or better intraocular pressure under 21 mmHg spherical equivalent of ± 5.00 diopters clear media and vitreous
Intervention groups
30 patients with NPDR or SNPDR who go to laser clinic by explaining the research plan for patients and their satisfaction. In this plan, each patient's retest is divided into four parts (ST/SN/IT/IN) and in each session one area of each eye of the patient is lasered;Each visit is used in a different way to reduce the patient's pain during laser, for example: the patient receives novafen capsules alone in the first session of the visit, in the second session, the pregabalin capsule and in the third session, the combination of two drugs and in the fourth session placebo will receive placebo.
Main outcome variables
patient scored the pain sensation immediately after each PRP section using Scott& rsquo s visual analogue scale (VAS).
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200915048724N1
Registration date:2020-10-29, 1399/08/08
Registration timing:registered_while_recruiting
Last update:2020-10-29, 1399/08/08
Update count:0
Registration date
2020-10-29, 1399/08/08
Registrant information
Name
Mohammadkarim johari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3230 2830
Email address
mkjoharii@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-22, 1399/08/01
Expected recruitment end date
2021-05-20, 1400/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of oral pain relief cocktail during panretinal photocoagulation for diabetic retinopathy: a randomized clinical trial
Public title
The efficacy of oral pain relief cocktail during panretinal photocoagulation for diabetic retinopathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age: years old
proliferative diabetic retinopathy severe non-proliferative diabetic retinopathy
no previous laser treatment
best corrected visual acuity of 20/200 or better
intraocular pressure under 21 mmHg
spherical equivalent of ± 5.00 diopters
clear media and vitreous
severe non-proliferative diabetic retinopathy
Exclusion criteria:
previous photocoagulation treatment
media opacity such as cataracts, corneal diseases or vitreous hemorrhage
unilateral PDR
chronic use of analgesics
history of any side effects related to pregabalin or novafen
Myopic more or equal to 6
Renal Failure
Age
From 51 years old to 69 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
30
More than 1 sample in each individual
Number of samples in each individual:
2
both eyes of each patient
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, a simple randomization method using a table of random numbers has been used. 30 patients are included in this study. Depending on the time of enrollment, a number from 1 to 30 is assigned to each patient. Each patient needs four sessions of laser treatment. Also, for each patient, four pain relief interventions are considered, which are marked with the letters A, B, C, D. For each laser treatment session, based on the table of random numbers in the first row from left to right, the last two digits and the number 00-24 for intervention A and 25-49 for intervention B and 50-74 for intervention C and 75-99 for intervention D are considered.
After determining the sequence of interventions for 30 patients, opaque envelopes were used for concealment. The order of interventions is placed on cards in the envelope and each envelope is assigned to one patient. During the treatment, a third person delivers the analgesic drug to the patient based on this sequence before the laser.
Blinding (investigator's opinion)
Double blinded
Blinding description
The present study is an interventional double-blind randomized clinical trial in which a specialist and patient will not know the type of medication received at each stage.Each patient will be given numbers from 1 to 30 and each number will be entered in the randomization table and according to the table, one of the four treatment plan will be performed at each patient's visit. The nurse who delivers the drug to the patient according to the randomization table is aware of the type of medication.The data collector and those who assess the outcome are unaware of the type of drug used.
Placebo
Used
Assignment
Crossover
Other design features
Oral medications were given one hour before PRP. Pain sensation is assessed immediately after treatment by verbal rating scale, which is a useful clinical pain index for pain intensity in postoperative patients. The verbal scale included a range of 0 (painless in all), 1 (slight discomfort), 2 (mild pain), 3 (moderate pain), 4 (severe pain), up to 5 (very painful). Blood pressure and heart rate are recorded by a digital blood pressure monitor 15 minutes before and immediately after treatment. Before laser treatment, measurements are performed after rest for at least 15 minutes. The statistics of the variables described as standard mean and deviation are expressed. The retin of each patient entering the study is divided into four regions :(ST/SN/IT/IN) and one area of two eyes is lasered in each session. According to the random table, each patient will be given one of the four treatment plan before laser and the patient's pain will be recorded immediately.
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 central building, Zand BLVD, Shiraz,
Diabetes mellitus due to underlying condition with mild nonproliferative diabetic retinopathy with macular edema
Primary outcomes
1
Description
Pain in VAS Questionnaire
Timepoint
patient scored the pain sensation immediately after each PRP section using Scott& rsquo s visual analogue scale (VAS).
Method of measurement
visual analogue scale (VAS).
Secondary outcomes
1
Description
Blood pressure
Timepoint
Blood pressure were taken by a digital blood pressure monitor 15 min before and immediately after laser treatment.
Method of measurement
digital blood pressure monitor
Intervention groups
1
Description
Intervention group: At first, 30 patients (60 eyes) are studied, each patient's retin is divided into four parts and in each session one area of each eye is lasered one hour before the laser according to the drug randomization table is given to the patient. This drug can be placebo, navafen,150mg capsule combination of navafen and150mg capsule pregabalin.The patient's pain sensation will be measured immediately after each PRP ward using the Visual AnalogUe Scale (VAS). In four sessions for laser one-quarter retin, he receives three sessions of analgesics and in one placebo session.
Category
Treatment - Surgery
2
Description
Control group: In this study, each patient receives three sessions of analgesics in four sessions for one-quarter retin laser and in one placebo session.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Motahari Clinic, Shiraz University of Medical Sciences
Full name of responsible person
Mohammad karim Johari
Street address
Shiraz University of Medical Sciences central building, Zand BLVD, Shiraz,
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3230 5410
Email
mkjoharii@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad karim Johari
Street address
Shiraz University of Medical Sciences central building, Zand BLVD, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3230 5410
Email
mkjoharii@gmail.com
Grant name
Shiraz University of Medical Sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad hossein norouzzade
Position
associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
Shiraz University of Medical Sciences central building, Zand BLVD, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3230 5410
Email
mkjoharii@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad karim Johari
Position
associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
Shiraz University of Medical Sciences central building, Zand BLVD, Shiraz,
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3230 5410
Email
mkjoharii@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad karim Johari
Position
associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
Shiraz University of Medical Sciences central building, Zand BLVD, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3230 5410
Email
mkjoharii@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
All potential data is shareable after people are identified
When the data will become available and for how long
Start of access period 6 months after printing results
To whom data/document is available
Researchers working in academic and scientific institutions and people who are also engaged in the industry
Under which criteria data/document could be used
No other terms for using data or documentation
From where data/document is obtainable
mkjoharii@gmail.com
Mohammad karim Johari
What processes are involved for a request to access data/document