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

This study has been completed.
Sponsor:
Information provided by:
Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT00893100
First received: April 19, 2009
Last updated: May 2, 2009
Last verified: May 2009
  Purpose

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


Condition Intervention Phase
Pain
Drug: Diltiazem
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: Evaluation of Pain Reduction After Hemorrhoidectomy With Use of Diltiazim Ointment 2%

Resource links provided by NLM:


Further study details as provided by Tehran University of Medical Sciences:

Primary Outcome Measures:
  • Reduction of Pain [ Time Frame: daily in one week ] [ Designated as safety issue: Yes ]

Enrollment: 1
Study Start Date: October 2007
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Diltiazem Drug: Diltiazem
2%,3 times daily
Other Name: Diltiazem

Detailed 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00893100

Locations
Iran, Islamic Republic of
Sina General Hospital
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Tehran University of Medical Sciences
Investigators
Principal Investigator: Farshad Jalili, Resident Sina Hospital
  More Information

No publications provided

Responsible Party: Bagher Larijani
ClinicalTrials.gov Identifier: NCT00893100     History of Changes
Other Study ID Numbers: 724
Study First Received: April 19, 2009
Last Updated: May 2, 2009
Health Authority: United States: Food and Drug Administration
Iran: Ministry of Health

Additional relevant MeSH terms:
Diltiazem
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Antihypertensive Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on July 28, 2014