Protocol summary

Summary
Introduction and background: Pain and its control is one of the health problems in the world. Vein Puncture is one of the most usual invasive procedures performed by nurses. So finding methods to decrease the pain caused by vein puncture is very important. Objectives: The present study was planned to evaluate the efficacy of applying Diclofenac gel and EMLA (Eutectic mixture of local anesthetics) ointment on vein puncture pain severity with vein catheter in the patients undergoing cesarean section. Design, Setting and conduct: This is a randomized, single blind, placebo controlled clinical trial that was conducted on 90 women undergoing cesarean section in Imam Ali Hospital’s maternity section in Amol city. Between 9th of April 2010 and 10th of June 2010 eligible patients were randomly divided into EMLA group (E group), Diclofenac group (D group) or Placebo group (P group) in equal numbers. Study Entry Requirements: aged 18 to 40 years; don’t have any defect in terms of mental and visual and verbal ability; Patients who doesn’t have any sensitivity to local anaesthetics or allergy to NSAIDs; haven’t used analgesics during the previous 24 hours; don’t have Favism, methemoglobin, liver and kidney disease, asthma, skin allergies, skin dermatitis, wound in the area assigned for intervention, active gastrointestinal bleeding, allergies to topical anaesthetics and non steroidal anti-inflammatory drugs included in this study. Study Exclusion: if the insertion vein catheter be unsuccessful in the first attempt or the caesarean section become an emergency operation. Interventions: for the Patients in D Group used diclofenac gel, E Group used EMLA ointment and P Group used Vaseline ointment in the area of the catheter insertion one hour before catheter insertion. Main outcome measures: The severity was pain. Background variables: age, history of the installation of vein catheter, having therapeutic support systems, level of monthly income and the level of the patient’s education.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201008234618N1
Registration date: 2010-09-09, 1389/06/18
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2010-09-09, 1389/06/18
Registrant information
Name
Sediqeh Khalili
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 15 1214 4000
Email address
khalili@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2010-04-09, 1389/01/20
Expected recruitment end date
2010-06-10, 1389/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical Trial "Assessment of the effect of Diclofenac gel and EMLA ointment on vein puncture pain severity with vein catheter in patient undergoing cesarean section"
Public title
Clinical Trial "Assessment of the effect of Diclofenac gel and EMLA" ointment"
Purpose
Prevention
Inclusion/Exclusion criteria
Study Entry Requirements: aged 18 to 40 years; don’t have any defect in terms of mental and visual and verbal ability; Patients who doesn’t have any sensitivity to local anaesthetics or allergy to NSAIDs; haven’t used analgesics during the previous 24 hours; don’t have Favism, methemoglobin, liver and kidney disease, asthma, skin allergies, skin dermatitis, wound in the area assigned for intervention, active gastrointestinal bleeding, allergies to topical anaesthetics and non steroidal anti-inflammatory drugs included in this study. Study Exclusion: if the insertion vein catheter be unsuccessful in the first attempt or the caesarean section become an emergency operation.
Age
From 18 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Islamic Azad University, Medical Sciences Tehran
Street address
Shariaty, Zargande
City
Tehran
Postal code
19168
Approval date
2010-04-29, 1389/02/09
Ethics committee reference number
2927

Health conditions studied

1

Description of health condition studied
Diclofenac gel on vein puncture pain severity with vein catheter
ICD-10 code
Y45.3
ICD-10 code description
Other nonsteroidal anti-inflammatory drugs

2

Description of health condition studied
EMLA ointment on vein puncture pain severity with vein catheter
ICD-10 code
Y48.3
ICD-10 code description
Local anaesthetics

Primary outcomes

1

Description
vein puncture pain severity with vein catheter
Timepoint
3-5 minutes after vein catheter installation
Method of measurement
Visual analogue scale

Secondary outcomes

1

Description
Short-term effects of topical drugs diclofenac gel, anesthetic cream EMLA and vaseline cream
Timepoint
application local medications later One hour
Method of measurement
Checklist of short-term effects of topical drugs

Intervention groups

1

Description
Researcher put the size of 2 g of EMLA ointment (EMLA ointment 5% mixture of lidocaine 2.5% and 2.5% prilocaine Manufactured by Tehran Chemie Pharmaceutical Co. Tehran - Iran, that containing 30 - gram tubes with confirmation Ministry of Health) in the level of the 2.5 × 4 cm EMLA group ointment on the behind at the left hand, before an hour catheter insertion and covered the area with transparent dressing.
Category
Prevention

2

Description
Researcher put the size of 100 mg of diclofenac gel (diclofenac gel 1% Each 100 grams contains: diclofenac Diethyl ammonium equivalent to diclofenac sodium 1 g, Manufactured by Behvzan Co. Rasht - Iran that containing 60 grams tubes with confirmation Ministry of Health) in the level of the 1.9 × 3.8 cm diclofenac group gel on the behind at the left hand, before an hour catheter insertion and covered the area with transparent dressing.
Category
Prevention

3

Description
Researcher put the size of 100 mg of Vaseline ointment (Vaseline ointment compounds that liquid paraffin and glycerin, Lanolin and Fragrance free, Manufactured by Pars Hayan Co. Iran that containing 45 grams tubes with confirmation Ministry of Health) in the level of the 1.9 × 3.8 cm placed group on the behind at the left hand, before an hour catheter insertion and covered the area with transparent dressing.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Ali Hospital
Full name of responsible person
Sediqeh Khalili graduate student orientation Surgical Nursing Education
Street address
Nour Street
City
Amol

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Sediqeh Khalili (personal)
Full name of responsible person
Sediqeh Khalili
Street address
37, 4th Fajr street, Nour Street
City
Amol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sediqeh Khalili (personal)
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
Mazandaran University of Medical Sciences
Full name of responsible person
Sediqeh Khalili
Position
Nurse / Postgraduate Nursing Student
Other areas of specialty/work
Street address
Joybar Three-way, Imam Square
City
Sari
Postal code
4815733971
Phone
+98 15 1214 4000
Fax
+98 15 1226 2569
Email
khalili@mazums.ac.ir
Web page address
www.mazums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University, Tehran Medical
Full name of responsible person
Sediqeh Khalili
Position
Nursing graduate student
Other areas of specialty/work
Street address
Shariati, Zargndeh
City
Tehran
Postal code
19168
Phone
+98 21220066607
Fax
+98 21 2200 8049
Email
shomia@ymail.com
Web page address
www.iautmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Sediqeh Khalili
Position
Nurse / Postgraduate Nursing Student
Other areas of specialty/work
Street address
Joybar Three-way, Imam Square
City
Sari
Postal code
4815733971
Phone
+98 15 1214 4000
Fax
+98 15 1225 2725
Email
khalili@mazums.ac.ir
Web page address
www.mazums.ac.ir

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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