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Comparison of Sublingual Misoprostol Versus Lidocaine Spray for Hysteroscopy

Information source: Dr. Sami Ulus Children's Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pain During Hysteroscopy

Intervention: Sublingual Misoprostol (Drug); Lidocaine pump spray (Drug); Placebo (for Misoprostol) (Drug); Placebo (for Lidocaine) (Drug)

Phase: N/A

Status: Completed

Sponsored by: Dr. Sami Ulus Children's Hospital

Official(s) and/or principal investigator(s):
Tuncay Kucukozkan, Professor, Study Chair, Affiliation: Sami Ulus Maternity and Childrens Hospital

Summary

Hysteroscopy is an instrument to visualize the interior walls of uterus (womb) and it enables the doctor to do minor operative procedures. Although it causes little discomfort, sometimes it may be disturbing for the patient. This pain is usually perceived during the passage of the instrument through the cervix (neck of the womb). The investigators would like to minimize this pain by two drugs: Misoprotol and lidocaine

Clinical Details

Official title: Comparison of Sublingual Misoprostol Versus Lidocaine Spray for Pain Relief in Office Hysteroscopy: A Randomized, Double Blind, Placebo-Controlled Trial

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Patient VAS score immediately after the procedure

Secondary outcome: Patient VAS score 10 minutes after the procedure

Detailed description: Outpatient or office hysteroscopy has become the 'gold standard' for the investigation of the intrauterine abnormalities. This minimal invasive modality provides brilliant and clear visualization of the entire uterine cavity and besides this, by the operative channel, minor procedures may easily be performed in the office setting which is priceless for the gynecologist. However, pain related to the procedure may make the procedure uncomfortable for the patient and the physician. Together with the operative time, hysteroscope diameter is considered as the main factor influencing pain. The pain perceived during hysteroscopy may be reduced by using a smaller diameter hysteroscope or by using anesthesia, which decreases pain perception. In this prospective, randomized, double blind, placebo controlled study, we aim to compare the effectiveness of sublingual misoprostol versus lidocaine pump spray for pain relief during office hysteroscopy.

Eligibility

Minimum age: 18 Years. Maximum age: 51 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Premenopausal women in the proliferative phase of the menstrual cycle with no

contraindication for hysteroscopy Exclusion Criteria:

- vaginal bleeding at the time of the procedure

- known sensitivity to lidocaine (amide group local anesthetics) or prostaglandins

- epilepsy

- significantly impaired respiratory or cardiac conduction functions

- hypertension

- glaucoma

- renal failure

- acute liver disease

- uncontrolled diabetes mellitus

- pregnancy or suspicion of pregnancy

- pelvic inflammatory disease

- cervical operation history

- vaginismus.

Locations and Contacts

Dr Sami Ulus Maternity and Children Training and Research Hospital, Ankara 06090, Turkey
Additional Information

Starting date: March 2008
Last updated: October 30, 2012

Page last updated: August 23, 2015

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