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

NCT ID: NCT02016976

Last Updated: 2013-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2014-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pacemaker Implantation Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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EMLA analgesic cream

Patients who have had EMLA analgesic cream applied to area before pacemaker implantation

Group Type ACTIVE_COMPARATOR

EMLA Analgesic Cream

Intervention Type DRUG

Routine treatment

Patients who have received routine treatment (Dormicum 2.5 mg and Pethidine 25 mg) before and during pacemaker implantation

Group Type ACTIVE_COMPARATOR

Dormicum 2.5 mg and Pethidine 25 mg

Intervention Type DRUG

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

Interventions

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EMLA Analgesic Cream

Intervention Type DRUG

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* All patients undergoing pacemaker implantation

Exclusion Criteria

* Dementia Patients
* Psychiatric Patients
* Unconscious Patients
* Patients with sensitivity to EMLA
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hillel Yaffe Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hillel Yaffe Medical Center

Hadera, , Israel

Site Status

Countries

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Israel

Central Contacts

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Anat Glass, RN, MA

Role: CONTACT

Phone: 972-52-8335558

Email: [email protected]

Facility Contacts

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Anat Glass, RN, MA

Role: primary

Other Identifiers

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0094-13-HYMC

Identifier Type: -

Identifier Source: org_study_id