Intrauterine device (IUD) is one of the most efficient contraceptive methods. but, IUD insertion is accompanied by pain and discomfort. This study evaluated the analgesic effects of 10% Lidocaine spray in reducing IUD insertion pain.
In a randomized clinical trial, 80 volunteers for IUD insertion were selected from women who reefer to Urmia Nikkhah Urban Health Center and randomly allocated to two groups. The intervention group received four puffs of 10% Lidocaine spray (40 mg) on their cervix prior to IUD insertion. The routine procedure (without an analgesic) was followed in the control group. Then IUD insertion was done in Litatomy position by ministry of health guideline. The intensity of perceived pain in both groups was measured using a visual analog scale 0 to 10 Cm and the data was analyzed by statistical methods.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017042333608N1
Registration date:2017-10-15, 1396/07/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-10-15, 1396/07/23
Registrant information
Name
Maryam Hajiesmaello
Name of organization / entity
Urmia Branch, Islamic Azad University
Country
Iran (Islamic Republic of)
Phone
+98 44 3348 0140
Email address
m.hajiesmailou@iaurmia.ac.ir
Recruitment status
Recruitment complete
Funding source
Urmia Branch, Islamic Azad University
Expected recruitment start date
2014-03-11, 1392/12/20
Expected recruitment end date
2014-09-21, 1393/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of The Effect of 10% Lidocaine Spray on Reducing the Pain of IUD Insertion
Public title
Evaluation of The Effect of 10% Lidocaine Spray on Reducing the Pain of IUD Insertion
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria: No allergies to Lidocaine; Haven't received analgesics and narcotics during the 24 hours before IUD insertion; History of childbirth up to 3 times; no any contraindication for IUD insertion (suspected pregnancy; history of pelvic inflammatory disease; abnormal uterine anatomy; Wilson’s disease; unexplained vaginal bleeding and cervical malignancy)
Exclusion Criteria: Problem to IUD insertion; uterine size smaller than 6 cm or larger than 9 cm.
Age
From 18 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice Chancellor for Health of Urmia University of Medical Sciences
Street address
Vice Chancellor for Health of Urmia University of Medical Sciences, Orjans Town, Resalat Blv, Urmia, Iran
City
Urmia
Postal code
5714783734
Approval date
2014-02-24, 1392/12/05
Ethics committee reference number
P/05124284/92
Health conditions studied
1
Description of health condition studied
The Effect of 10% Lidocaine Spray on Reducing the Pain of IUD Insertion
ICD-10 code
-
ICD-10 code description
-
Primary outcomes
1
Description
Pain
Timepoint
Pain at baseline and during and after IUD insertion.
Method of measurement
Visual Scale Analog
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group received local anesthetic by four puffs of 10% lidocaine (40 mg) at cervical area three minutes prior to IUD insertion
Category
Prevention
2
Description
The control group (routine IUD insertion without analgesia)
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Urmia Nikkhah Urban Health Center
Full name of responsible person
Poone Ebne AbdolAli
Street address
Urmia Nikkhah Urban Health Center, Near West Terminal, Dokhaniat Junc, Urmia, Iran
City
Urmia
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor For Research Of Urmia Branch, Islamic Azad University
Full name of responsible person
Nazanin Shafiee
Street address
Urmia Branch, Islamic Azad University, 2th Kilumeter of Airport road, Urmia, Iran
City
Urmia
Grant name
Grant code / Reference number
1039508050035
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor For Research Of Urmia Branch, Islamic Azad University
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
Urmia Branch, Islamic Azad University
Full name of responsible person
Maryam Hajiesmaello
Position
MSc of Midwifery, Faculty Lecturer
Other areas of specialty/work
Street address
Urmia Branch, Islamic Azad University, 2th Kilumeter of Airport road, Urmia, Iran