Lidocaine-Prilocaine (EMLA) Cream as Analgesia in Hysteroscopy Practice
Information source: Consorci Sanitari de Terrassa
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain
Intervention: lidocaine-prilocaine cream (Drug); gel application for the transmission of ultrasound (Other)
Phase: Phase 4
Status: Completed
Sponsored by: Consorci Sanitari de Terrassa Official(s) and/or principal investigator(s): Baldomero Arnau, MD, PhD, Principal Investigator, Affiliation: Consorci Sanitari de Terrassa
Summary
The purpose of this study is to demonstrate that Lidocaine-Prilocaine cream decrease pain
during hysteroscopy diagnostic practice.
Clinical Details
Official title: Lidocaine-Prilocaine (EMLA) Cream as Analgesia in Hysteroscopy Practice: a Prospective Randomized Clinical Trial
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: pain reduction in the performance of hysteroscopy
Secondary outcome: sense of discomfort experience during the procedure
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- patients that he must perform a diagnostic hysteroscopy
- acceptance to participate in the study signed informed consent
Exclusion Criteria prerandomization:
- hypersensitivity or allergy to anesthetics
- refusal of the patient
- patients under age 18 and pregnant
Exclusion Criteria postrandomization:
- dropout
- unbearable pain that involves other analgesic measures
- allergic reactions to topical anesthetics
Locations and Contacts
Consorci Sanitari de Terrassa, Terrassa, Barcelona 08227, Spain
Additional Information
Starting date: July 2007
Last updated: April 8, 2010
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