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NCT02016976 Clinical Trial

Effect of Local Anesthetic EMLA (Lidocaine 2.5% and Prilocaine 2.5%) Cream and Reduction in Dose, Pain and Intravenous Analgesic During Permanent Pacemaker Implantation

Pain Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT02016976
Other study ID # 0094-13-HYMC
Secondary ID
Status Not yet recruiting
Phase N/A
First received December 16, 2013
Last updated December 19, 2013
Start date January 2014
Est. completion date August 2014

Study information
Verified date December 2013
Source Hillel Yaffe Medical Center
Contact Anat Glass, RN, MA
Phone 972-52-8335558
Email anatglass1@gmail.com
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial Summary

The investigators believe that the local anesthetic EMLA (Lidocaine 2.5% and Prilocaine 2.5%) cream will lessen pain and reduce the need for anesthesia and analgesia, when implanting a permanent pacemaker.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 40
Est. completion date August 2014
Est. primary completion date August 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- All patients undergoing pacemaker implantation

Exclusion Criteria:

- Dementia Patients

- Psychiatric Patients

- Unconscious Patients

- Patients with sensitivity to EMLA

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Intervention

Drug:
• EMLA Analgesic Cream

• Dormicum 2.5 mg and Pethidine 25 mg
Routine anesthesia and analgesia ( Dormicum 2.5 mg and Pethidine 25 mg )normally given to patients before and during pacemaker implantation

Locations
Country Name City State
Israel Hillel Yaffe Medical Center Hadera

Sponsors (1)
Lead Sponsor Collaborator
Hillel Yaffe Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pain reduction EMLA anesthetic cream will be applied to area where pacemaker is to be implanted. Pain reduction will be measured using the visual analog scale (VAS) at three intervals. One hour No
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