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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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2013 by Hillel Yaffe Medical Center.
Recruitment status was:  Not yet recruiting
Information provided by (Responsible Party):
Hillel Yaffe Medical Center Identifier:
First received: December 16, 2013
Last updated: December 19, 2013
Last verified: December 2013
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.

Condition Intervention
Pacemaker Implantation
Drug: EMLA Analgesic Cream
Drug: Dormicum 2.5 mg and Pethidine 25 mg

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care

Further study details as provided by Hillel Yaffe Medical Center:

Primary Outcome Measures:
  • Pain reduction [ Time Frame: 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.

Estimated Enrollment: 40
Study Start Date: January 2014
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: EMLA analgesic cream
Patients who have had EMLA analgesic cream applied to area before pacemaker implantation
Drug: EMLA Analgesic Cream
Active Comparator: Routine treatment
Patients who have received routine treatment (Dormicum 2.5 mg and Pethidine 25 mg) before and during pacemaker implantation
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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • All patients undergoing pacemaker implantation

Exclusion Criteria:

  • Dementia Patients
  • Psychiatric Patients
  • Unconscious Patients
  • Patients with sensitivity to EMLA
  Contacts and Locations
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Please refer to this study by its identifier: NCT02016976

Contact: Anat Glass, RN, MA 972-52-8335558

Hillel Yaffe Medical Center Not yet recruiting
Hadera, Israel, 38100
Contact: Anat Glass, RN, MA    972-52-8335558   
Principal Investigator: Anat Glass, RN, MA         
Sponsors and Collaborators
Hillel Yaffe Medical Center
  More Information

Responsible Party: Hillel Yaffe Medical Center Identifier: NCT02016976     History of Changes
Other Study ID Numbers: 0094-13-HYMC
Study First Received: December 16, 2013
Last Updated: December 19, 2013

Additional relevant MeSH terms:
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Combined
Adjuvants, Anesthesia
Hypnotics and Sedatives
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics processed this record on May 25, 2017