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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

Page last updated: August 23, 2015

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