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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

Tracking Information
First Submitted Date  ICMJE December 11, 2013
First Posted Date  ICMJE December 25, 2013
Last Update Posted Date December 25, 2013
Study Start Date  ICMJE May 2013
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 24, 2013)
Pain [ Time Frame: 3 months ]
10 cm VAS scale
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lidocaine 10% Spray Reduces Pain During Intrauterine Device Insertion
Official Title  ICMJE Not Provided
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Pain
Intervention  ICMJE
  • Drug: Lidocaine Spray
  • Drug: Placebo
Study Arms  ICMJE
  • Placebo Comparator: saline spray application
    Placebo group
    Intervention: Drug: Placebo
  • Experimental: lidocaine spray application
    2 puff lidocaine spray applicated before IUD insertion
    Intervention: Drug: Lidocaine Spray
Publications * Aksoy H, Aksoy Ü, Ozyurt S, Açmaz G, Babayigit M. Lidocaine 10% spray to the cervix reduces pain during intrauterine device insertion: a double-blind randomised controlled trial. J Fam Plann Reprod Health Care. 2016 Apr;42(2):83-7. doi: 10.1136/jfprhc-2014-100917. Epub 2015 Mar 10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 24, 2013)
223
Original Actual Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Age >18 Not pregnant Smear negative

Exclusion Criteria:

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

Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 49 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02020551
Other Study ID Numbers  ICMJE kerhGA
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gökhan Açmaz, Kayseri Education and Research Hospital
Study Sponsor  ICMJE Kayseri Education and Research Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Kayseri Education and Research Hospital
Verification Date December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP