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Comparison of two topical piroxicam and EMLA cream on fistula cannulation pain in hemodialysis patient

Protocol summary

Summary
Hemodialysis is the most common alternative therapeutic in patients with renal failure, which is used in Iran and the world. Widespread access to dialysis makes the lives hundreds of thousands patients with end-stage renal disease(ESRD) has longed.This process leads to repeated stress and pain to fistula cannulation. If can relieve this pain, improve treatment compliance and improve the quality of life in patients. The purpose of this study was to determine the effectiveness of two topical piroxicam and EMLA cream on fistula cannulation pain on hemodialysis patients. Study is trial, randomized, double-blind, controlled with placebo. The sample consisted of 75 dialysis patients (not suffering from psychological problems, addiction, chronic and acute pain or etc) with stratified method by age, gender, educational level and duration of fistula are blocking three Group A (piroxicam group), B (group EMLA cream) and C (control group) with equal numbers. In the first session of dialysis fistula cannulation procedure done without any interference and pain with using the VAS scale recorded. At the end of this session ,ointment tube that surface is covered with a transparent dressing disposal to patients. In the second session (next sessions of dialysis) for an hour before coming to the hospital, the patient rubbed ointment, covered with a transparent dressing and then cannulation is performed in the usual way and the pain is recorded. If unsuccessful on the first attempt and repeated needle cannulation of the skin, patient are excluded.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013051213301N1
Registration date: 2013-05-24, 1392/03/03
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-05-24, 1392/03/03
Registrant information
Name
Mahdi Mohseni
Name of organization / entity
Lorestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 66 1620 0140
Email address
mohseni_m1989@yahoo.com
Recruitment status
Recruitment complete
Funding source
Lorestan University of Medical Sciences
Expected recruitment start date
2013-04-25, 1392/02/05
Expected recruitment end date
2013-05-26, 1392/03/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of two topical piroxicam and EMLA cream on fistula cannulation pain in hemodialysis patient
Public title
Comparison of two topical piroxicam and EMLA cream on fistula cannulation pain in hemodialysis patient
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: 1. The patient is willing to cooperate and participate in the research. 2. The patient has given informed consent to participate in research. 3. Age is between 18-80 years old. 4. Starting hemodialysis at lease 3 months before. 5. Patients don’t have verbal disability, mental and vision problems. 6. Patients don’t have prior history of mental illness or psychiatric hospitalization. 7. The patient is not addict. 8. The patient has no pain medication dependency. 9. The patient has no pain before cannulation. 10. The patient has not used sedative drugs in the last 24 hours of cannulation . 11. The fistula skin is not injured. 12. Patients don’t have history of G6PD, congenital or idiopathic Methemoglobinemia, liver disease, asthma, skin allergies, dermatitis, rash, thrombophlebitis, gastrointestinal bleeding. 13. Patients don’t have sensitivity to local anesthetic drugs, nonsteroidal anti-inflammatory drugs and other medicines. 14. Patients not be treated with sulfonamide drugs, nitrates and phenobarbital. Exclusion criteria: 1. Patient does not wish to continue research. 2. The patient is referred to another center. 3. If unsuccessful on the first attempt and repeated cannulation needle into the skin.
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 75
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Lorestan University of Medical Sciences Ethics Committee
Street address
Lorestan University of Medical Sciences and Health Services, Research, Ethics Committee.
City
Khorramabad
Postal code
381351698
Approval date
2013-04-22, 1392/02/02
Ethics committee reference number
20084258

Health conditions studied

1

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

Primary outcomes

1

Description
the pain of fistula cannulation
Timepoint
firstly without interference - the second after intervention
Method of measurement
visual pain scale

Secondary outcomes

1

Description
Short-term effects of topical drugs (piroxicam, EMLA cream and ointment A + D)
Timepoint
one hour after the drug
Method of measurement
observed effects

Intervention groups

1

Description
Group A or Group piroxicam in the first session dialysis procedure and without any interference cannulation performed at the second session an hour before cannulation of 2 g of piroxicam in fistula rubbed with gauze transparent is covered.
Category
Treatment - Drugs

2

Description
Group B or Group ointment Spelling: In the first session dialysis procedure and without any interference cannulation performed at the second session an hour before cannulation of 2 g of ointment spelling fistula rubbed with gauze transparent is covered.
Category
Treatment - Drugs

3

Description
Group C or placebo in the first session dialysis procedure and without any interference cannulation performed at the second session an hour before cannulation of 2 g of ointment A + D in fistula rubbed with gauze transparent is covered.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Shohada Hospital in Khorramabad
Full name of responsible person
Mehdi Mohseni
Street address
Revolution Street, Shohada Hospital
City
Khorramabad.

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Lorestan University of Medical Sciences, Research
Full name of responsible person
Dr. Mohamed Hassan Kaydy
Street address
Lorestan University of Medical Sciences and Health Services, Research.
City
Khorramabad.
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Lorestan University of Medical Sciences, Research
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
Lorestan University of Medical Sciences
Full name of responsible person
Mehdi Mohseni
Position
Masters student in nursing
Other areas of specialty/work
Street address
Lorestan University of Medical Sciences, School of Nursing and Midwifery, Department of Nursing.
City
Khorramabad.
Postal code
381351698
Phone
+98 66 1620 0140
Fax
+98 66 1620 0138
Email
mohseni_m1989@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Lorestan University of Medical Sciences
Full name of responsible person
Malekshahi ّFaride
Position
PhD student Nursing
Other areas of specialty/work
Street address
Lorestan University of Medical Sciences, School of Nursing and Midwifery, Department of Nursing.
City
Khorramabad.
Postal code
381351698
Phone
+98 66 1620 0140
Fax
+98 66 1620 0138
Email
malekshahif@lums.ac.ir; malekshahif@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Lorestan University of Medical Sciences
Full name of responsible person
Mehdi Mohseni
Position
Masters student in nursing
Other areas of specialty/work
Street address
Lorestan University of Medical Sciences, School of Nursing and Midwifery, Department of Nursing.
City
Khorramabad.
Postal code
381351698
Phone
+98 66 1620 0140
Fax
+98 66 1620 0138
Email
mohseni_m1989@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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