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Lidocaine-Prilocaine (EMLA) Cream as Analgesia in Hysteroscopy Practice

Phase 4
Completed
Conditions
Pain
Interventions
Drug: lidocaine-prilocaine cream
Other: gel application for the transmission of ultrasound
Registration Number
NCT01094015
Lead Sponsor
Consorci Sanitari de Terrassa
Brief Summary

The purpose of this study is to demonstrate that Lidocaine-Prilocaine cream decrease pain during hysteroscopy diagnostic practice.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
92
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
Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Lidocaine-Prilocaine creamlidocaine-prilocaine cream-
placebogel application for the transmission of ultrasound-
Primary Outcome Measures
NameTimeMethod
pain reduction in the performance of hysteroscopyafter hysteroscopy and a month later

decrease in pain immediately after the completion of hysteroscopy and one month after completion of the diagnostic test by an analogue pain scale

Secondary Outcome Measures
NameTimeMethod
sense of discomfort experience during the procedurea month after hysteroscopy

willingness to repeat the diagnostic technique

Trial Locations

Locations (1)

Consorci Sanitari de Terrassa

🇪🇸

Terrassa, Barcelona, Spain

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