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Lidocaine 10% Spray Reduces Pain During Intrauterine Device Insertion

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02020551
Recruitment Status : Completed
First Posted : December 25, 2013
Last Update Posted : December 25, 2013
Information provided by (Responsible Party):
Gökhan Açmaz, Kayseri Education and Research Hospital

Brief Summary:
Pain during intrauterine device (IUD) insertion can be a barrier to initiation. Misoprostol and nonsteroidal drugs have found to be ineffective by clinical trials.Investigators tested whether intracervical 2% lidocaine gel decreased insertion pain compared to placebo.

Condition or disease Intervention/treatment Phase
Pain Drug: Lidocaine Spray Drug: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 223 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Study Start Date : May 2013
Actual Primary Completion Date : August 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: saline spray application
Placebo group
Drug: Placebo
Experimental: lidocaine spray application
2 puff lidocaine spray applicated before IUD insertion
Drug: Lidocaine Spray

Primary Outcome Measures :
  1. Pain [ Time Frame: 3 months ]
    10 cm VAS scale

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

Age >18 Not pregnant Smear negative

Exclusion Criteria:

Chronic pelvic pain Pregnancy Uterine anomaly Fibroid Acute cervicitis Pelvic inflammatory disease Cervical stenosis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02020551

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Kayseri Education and Research Hospital of Medicine
Kayseri, Turkey, 380210
Sponsors and Collaborators
Kayseri Education and Research Hospital
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Gökhan Açmaz, MD, Kayseri Education and Research Hospital Identifier: NCT02020551    
Other Study ID Numbers: kerhGA
First Posted: December 25, 2013    Key Record Dates
Last Update Posted: December 25, 2013
Last Verified: December 2013
Keywords provided by Gökhan Açmaz, Kayseri Education and Research Hospital:
Scores During IUD insertion.
Additional relevant MeSH terms:
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Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action