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

Randomized clinical trial of the comparison of splinting/non splinting in prevention of superficial phlebitis following Amiodarone Injection in patients with Cardiac Arrhythmia

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
IRCT
Registry ID
IRCT2015061622768N1
Enrollment
60
Registered
2016-02-24
Start date
2016-03-05
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Phlebitis. Phlebitis and phlebitis of other sites

Interventions

Intervention 1: Intervention 1: Splinting of the Amiodarone injection site with 2types of splints (designed by Kalay-e Pezeshki-e Ghalb Company): one for of the wrist and the other for the elbow. Int
Prevention
Intervention 1: Splinting of the Amiodarone injection site with 2types of splints (designed by Kalay-e Pezeshki-e Ghalb Company): one for of the wrist and the other for the elbow
2: No splinting at the site of Amiodarone injection

Sponsors

Tehran University of Medical Sciences, Vice Chancellor For Research
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFarah Ayatollah Zadeh Esfahani

Tehran Heart Center Hospital

rose8a2001@yahoo.com bitadavoudi@yahoo.com pashang_mina@yahoo.com+98 21 8802 9708

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026