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
Sponsor
Hillel Yaffe Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT02016976
Collaborator
(none)
40
1
2
7
5.7
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Study Start Date
:
Jan 1, 2014
Anticipated Primary Completion Date
:
Aug 1, 2014
Anticipated Study Completion Date
:
Aug 1, 2014
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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
|
Outcome Measures
Primary Outcome Measures
- 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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hillel Yaffe Medical Center | Hadera | Israel | 38100 |
Sponsors and Collaborators
- Hillel Yaffe Medical Center
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier:
NCT02016976
Other Study ID Numbers:
- 0094-13-HYMC
First Posted:
Dec 20, 2013
Last Update Posted:
Dec 20, 2013
Last Verified:
Dec 1, 2013