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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified December 2013 by Hillel Yaffe Medical Center
Sponsor:
Information provided by (Responsible Party):
Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier:
NCT02016976
First received: December 16, 2013
Last updated: December 19, 2013
Last verified: December 2013
  Purpose

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
Pain
Drug: EMLA Analgesic Cream
Drug: Dormicum 2.5 mg and Pethidine 25 mg

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

Resource links provided by NLM:


Further study details as provided by Hillel Yaffe Medical Center:

Primary Outcome Measures:
  • Pain reduction [ Time Frame: One hour ] [ Designated as safety issue: No ]
    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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients undergoing pacemaker implantation

Exclusion Criteria:

  • Dementia Patients
  • Psychiatric Patients
  • Unconscious Patients
  • Patients with sensitivity to EMLA
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02016976

Contacts
Contact: Anat Glass, RN, MA 972-52-8335558 anatglass1@gmail.com

Locations
Israel
Hillel Yaffe Medical Center Not yet recruiting
Hadera, Israel, 38100
Contact: Anat Glass, RN, MA    972-52-8335558    anatglass1@gmail.com   
Principal Investigator: Anat Glass, RN, MA         
Sponsors and Collaborators
Hillel Yaffe Medical Center
  More Information

No publications provided

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

Additional relevant MeSH terms:
Analgesics
Analgesics, Opioid
Meperidine
Anesthetics, Local
EMLA
Midazolam
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics
Central Nervous System Depressants
Adjuvants, Anesthesia
Narcotics
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anesthetics, Combined

ClinicalTrials.gov processed this record on July 20, 2014