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Comparing the effectiveness or ineffectiveness of Valsalva maneuver and EMLA cream on level of venous cannulation pain

Protocol summary

Summary
The present study aims to compare the effect of Valsalva Maneuver and EMLA cream on level of venous cannulation pain. It is a single blind experimental study. 160 patients candidate to general surgeries including ear, nose and throat, ophthalmology and urology bedridden in Department of Internal Medicine, Hazrat Rasul hospital, Javanrud, Kermanshah were selected and randomly divided into 3 experiments groups and a control group. The first experiment group made use of EMLA cream, 30 mlg. After 40 minutes of applying the cream, venous cannulation was accomplished. Valsalva Maneuver was done on the second group through blowing in a plastic pipe connected to a Mercury barometer, and Valsalva Maneuver was accomplished for at least 20 seconds. Venous cannulation was accomplished immediately after that. In the third group, both EMLA cream and Valsalva Maneuver were conducted so that EMLA cream was applied and, after 40 minutes, Venous cannulation was accomplished immediately in conditions similar to the first group. Vaseline was applied to the control group, and Venous cannulation was conducted after 40 minutes. Then, barometer was used to check patients’ blood pressure. Heart beat and the percentage of arterial oxygen saturation were checked using Pulse Oximeter. Pain rate was measured 5 minutes before Venous cannulation and immediately after that. Inclusion criteria: avoiding Systemic analgesics; lack of neurologic defects; lack of respiratory, cardiac, glaucoma diseases; no skin allergy or Atopic dermatitis. Exclusion criteria: Intravenous cannula failure in the first attempt.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015062814333N37
Registration date: 2015-07-24, 1394/05/02
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-07-24, 1394/05/02
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kermanshah University of Medical Sciences
Expected recruitment start date
2015-07-23, 1394/05/01
Expected recruitment end date
2015-09-23, 1394/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effectiveness or ineffectiveness of Valsalva maneuver and EMLA cream on level of venous cannulation pain
Public title
A Comparative study of the effect of Valsalva maneuver and EMLA cream on level of venous cannulation pain
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: avoiding Systemic analgesics; lack of neurologic defects; lack of respiratory, cardiac, glaucoma diseases; no skin allergy or Atopic dermatitis. Exclusion criteria: Intravenous cannula failure in the first attempt.
Age
From 15 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 160
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomized by sealed envelope

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Vice chancellor for research, Kermanshah University of Medical Sciences
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Postal code
Approval date
2015-05-26, 1394/03/05
Ethics committee reference number
Kums.Rec.1394.21

Health conditions studied

1

Description of health condition studied
level of venous cannulation pain
ICD-10 code
Y60.6
ICD-10 code description
During aspiration, puncture and other catheterization

Primary outcomes

1

Description
Pain level
Timepoint
Immediately after catheter insertion
Method of measurement
Using NRS according to criterion score gained from 0 to 10

2

Description
Average venous pressure
Timepoint
5 minutes before venous cannulation and immediately after that
Method of measurement
Using barometer

3

Description
Heart beat
Timepoint
5 minutes before venous cannulation and immediately after that
Method of measurement
Using pulse oximeter

4

Description
Arterial oxygen saturation
Timepoint
5 minutes before venous cannulation and immediately after that
Method of measurement
Using pulse oximeter

Secondary outcomes

empty

Intervention groups

1

Description
The first group made use of EMLA cream, made by Astrazeneca,Eczacibasi Ltd, Turkey. Cream surface is covered by a piece of paper and a 2 cc syringe was used to apply 1 cc, or 2.5 mlg, of the cream on dependent hand where venous cannulation was conducted at 2.5×2.5 cm. after 40 minutes, the dressing was removed from cannulation point and the place was disinfected using cotton drained in alcohol. Then, BP18 IVC was used to do venous cannulation while the patient lay back and his head is against the cannulation point. Also, tourniquet was placed on his forearm.
Category
Treatment - Drugs

2

Description
Valsalva maneuver in the second group was accomplished through blowing in a plastic pipe connected to a mercury barometer (Easylife, china) and holding up mercury bar upper than 20 mmHg for at least 20 seconds. Immediately after that venous cannulation was done similar to the group using EMLA cream.
Category
Treatment - Drugs

3

Description
Both EMLA cream and Valsalva maneuver were applied to the third group. 40 minutes after applying EMLA cream and in similar conditions to the first group, venous cannulation was done immediately after Valsalva maneuver.
Category
Treatment - Drugs

4

Description
All the conditions to the group using EMLA cream were considered to the fourth group. the difference is that Vaseline (Kimiagar-Toos Ltd, Iran) is used in the fourth group instead of EMLA cream. After 40 minutes venous cannulaton was accomplished.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Hazrat Rasool Hospital, Javanrod
Full name of responsible person
Mahdi Babaei
Street address
Hazrat Rasool Hospital, Street of Baradarn Amini, Javanrod
City
Javanrod

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Kermanshah University of Medical Sciences
Full name of responsible person
Koroush Hamzehee
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Kermanshah University of Medical Sciences
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

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Rostam Jalali
Position
Assistance professor of Nursing Training
Other areas of specialty/work
Street address
School of Nursing & Midwifery, First of Dolatabad Boulvard,Eisar Square
City
Kermanshah
Postal code
Phone
+98 83 3827 9304
Fax
Email
KS_ jalali@yahoo.com
Web page address

Person responsible for updating data

Contact

Sharing plan

Deidentified Individual Participant Data Set (IPD)
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Study Protocol
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Statistical Analysis Plan
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Informed Consent Form
empty
Clinical Study Report
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Analytic Code
empty
Data Dictionary
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