EMLA Cream in Hysteroscopy Practice

Anesthetics, Local Clinical Trial

Official title:

Lidocaine-Prilocaine (EMLA®) Cream in Hysteroscopy Practice: A Prospective Randomized Non-blinded Controlled Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02640183
• Other study ID #: EMLA-Hsc
• Status: Not yet recruiting
• Phase: Phase 2
• First received: December 22, 2015
• Last updated: December 22, 2015
• Start date: September 2015
• Est. completion date: March 2016

Study information

• Verified date: December 2015
• Source: Ain Shams Maternity Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to investigate the efficacy of 5% lidocaine 25 mg-prilocaine 25 mg/g cream (EMLA®) applied to the uterine cervix for reducing pain during diagnostic hysteroscopy, using a visual analogue scale (VAS) for pain, and whether it can replace general anesthesia that may be required for some cases of office hysteroscopy.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 184
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients that must perform a diagnostic hysteroscopy.

2. Acceptance to participate in the study.

3. Signed informed consent.

4. Not taking analgesics (acetaminophen, ibuprofen, mefenamic acid) 6h before admission.

5. Absence of sedative use 24 h before admission

Exclusion Criteria:

1. Hypersensitivity or allergy to anesthetics

2. refusal of the patient

3. Patients under age 18 and pregnant.

4. Patients on anti-arrhythmic drugs due to possibility of drug interaction.

5. Unbearable pain that involves other analgesic measures.

6. Allergic reactions to topical anesthetics

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anesthetics, Local

Intervention

Drug:
• EMLA

Other:
• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams Maternity Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain experienced during the procedure scored using a VAS.	All women will be asked to score the pain they experienced during the procedure using a VAS that consists of a 10-cm line scaled from 0 to 10 (0 = no pain and 10 = severe pain). Women will be asked to verbally specify the number that represented their level of perceived pain intensity during the hysteroscopy immediately after the procedure.; After completing the hysteroscopy, women will be asked if they would recommend the procedure to other women, if they had wished to abandon the hysteroscopy, and whether they would repeat the procedure if needed.	Procedure	Yes