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

Not Applicable

• Conditions: Pacemaker Implantation; Pain
• Interventions: Drug: EMLA Analgesic Cream; Drug: Dormicum 2.5 mg and Pethidine 25 mg

• Registration Number: NCT02016976
• Lead Sponsor: Hillel Yaffe Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2013-12
• Study First Submitted: 2013-12-16
• Study First Submitted QC: 2013-12-19
• Last Update Submitted: 2013-12-19
• Study First Posted: 2013-12-20
• Last Update Posted: 2013-12-20
• Study Start: 2014-01
• Primary Completion: 2014-08
• Study Completion: 2014-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• All patients undergoing pacemaker implantation

Exclusion Criteria

• Dementia Patients
• Psychiatric Patients
• Unconscious Patients
• Patients with sensitivity to EMLA

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EMLA analgesic cream	EMLA Analgesic Cream	Patients who have had EMLA analgesic cream applied to area before pacemaker implantation
Routine treatment	Dormicum 2.5 mg and Pethidine 25 mg	Patients who have received routine treatment (Dormicum 2.5 mg and Pethidine 25 mg) before and during pacemaker implantation

Primary Outcome Measures

Name	Time	Method
Pain reduction	One hour	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.

Trial Locations

Locations (1)

Hillel Yaffe Medical Center; 🇮🇱 Hadera, Israel