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Lidocaine 10% Spray Reduces Pain During Intrauterine Device Insertion

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ClinicalTrials.gov Identifier: NCT02020551
Recruitment Status : Completed
First Posted : December 25, 2013
Last Update Posted : December 25, 2013
Sponsor:
Information provided by (Responsible Party):
Gökhan Açmaz, Kayseri Education and Research Hospital

Study Description
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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

Study Design
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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

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Arms and Interventions
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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


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


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

Inclusion Criteria:

Age >18 Not pregnant Smear negative

Exclusion Criteria:

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

Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02020551


Locations
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Turkey
Kayseri Education and Research Hospital of Medicine
Kayseri, Turkey, 380210
Sponsors and Collaborators
Kayseri Education and Research Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Gökhan Açmaz, MD, Kayseri Education and Research Hospital
ClinicalTrials.gov 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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Lidocaine
Anesthetics, Local
Anesthetics
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