NCT02016976

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 16, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 20, 2013

Completed
12 days until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

December 20, 2013

Status Verified

December 1, 2013

Enrollment Period

7 months

First QC Date

December 16, 2013

Last Update Submit

December 19, 2013

Conditions

Pacemaker ImplantationPain

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

EMLA analgesic cream

ACTIVE COMPARATOR

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

Drug: EMLA Analgesic Cream

Routine treatment

ACTIVE COMPARATOR

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

Interventions

EMLA Analgesic CreamDRUG
EMLA analgesic cream
Dormicum 2.5 mg and Pethidine 25 mgDRUG

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

Routine treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients undergoing pacemaker implantation

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hillel Yaffe Medical Center

Hadera, 38100, Israel

Location

MeSH Terms

Conditions

Pain

Interventions

MidazolamMeperidine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsIsonipecotic AcidsAcids, HeterocyclicPiperidinesHeterocyclic Compounds, 1-Ring

Central Study Contacts

Anat Glass, RN, MA

CONTACT

972-52-8335558anatglass1@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2013

First Posted

December 20, 2013

Study Start

January 1, 2014

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

December 20, 2013

Record last verified: 2013-12

Locations

IL(1)