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NCT00893100 Clinical Trial

Evaluation of Pain Reduction After Hemorrhoidectomy With Use of Diltiazim Ointment 2%

Pain Clinical Trial

Official title:
Evaluation of Pain Reduction After Hemorrhoidectomy With Use of Diltiazim Ointment 2%

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00893100
Other study ID # 724
Secondary ID
Status Completed
Phase Phase 4
First received April 19, 2009
Last updated May 2, 2009
Start date October 2007
Est. completion date December 2008

Study information
Verified date May 2009
Source Tehran University of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationIran: Ministry of Health
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the effectiveness of diltiazem ointment 2 percent in reducing pain after hemorrhoidectomy.

Description:

Pain after hemorrhoidectomy remains a major postsurgical complication.Therefore pain management in patients is an important goal.Many studies have focused on surgical techniques,preoperative and postoperative regimes.We assessed a randomised double blind placebo-controlled trial to evaluate the effect of diltiazem ointment after surgery.

Recruitment information / eligibility
Status Completed
Enrollment 1
Est. completion date December 2008
Est. primary completion date December 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Patients with grade 3 or 4 hemorrhoid who underwent Milligan-Morgan surgery.

Exclusion Criteria:

- Patients with a history of heart disease, blood pressure, orthostatic hypertension, hemorrhoidal surgery,or those who had previous adverse effect from calcium channel blocker drugs and also those who were pregnant.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Intervention

Drug:
• Diltiazem
2%,3 times daily

Locations
Country Name City State
Iran, Islamic Republic of Sina General Hospital Tehran

Sponsors (1)
Lead Sponsor Collaborator
Tehran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Reduction of Pain daily in one week Yes
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