Effect of Hand Splinting on the Prevention of Inflammation following Amiodarone Injection in Patients with Cardiac Arrhythmia

Phase 1

• Conditions: Phlebitis.; Phlebitis and phlebitis of other sites

• Registration Number: IRCT2015061622768N1
• Lead Sponsor: Tehran University of Medical Sciences, Vice Chancellor For Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1- Age between 18 and 65 years
2- Amiodarone administration for atrial fibrillation or ventricular tachycardia
3- Starting dose of Amiodarone administration at CCU
4- Informed consent of the patient regarding the use of the splint. In case of the patient’s incapacity, informed consent will be obtained from the patient’s first-degree relatives (e.g., parents). The patients will be reassured that their treatment course will not be affected by non-participation in the study.
Exclusion criteria:
1- History of cancer and chemotherapy, deep vein thrombosis, renal failure and dialysis, consumption of broad-spectrum antibiotics and steroids
2- Removal of the splint in consequence of the patient’s agitation
3- Refusal to give consent for participation in the study

Exclusion Criteria

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain. Timepoint: Checking the injection site for 24 hours, starting from 1 hour after the injection of Amiodarone. Method of measurement: Self-report of pain at the injection site.;Redness. Timepoint: Checking the injection site for 24 hours, starting from 1 hour after the injection of Amiodarone. Method of measurement: Checking the injection site for redness at 1 hour intervals.;Inflammation. Timepoint: Checking the injection site for 24 hours, starting from 1 hour after the injection of Amiodarone. Method of measurement: Checking the injection site for inflammation.

Secondary Outcome Measures

Name	Time	Method
Injection site infection. Timepoint: Observation and checking of the injection site at 1 hour intervals until the resolution of the signs of phlebitis. Method of measurement: The observation and checking of injection site.