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Treatment of Suspected Cholelithiasis With Nitroglycerin

Primary Purpose

COLIC, BILIARY TRACT DISEASES

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
sublingual nitroglycerine
Sponsored by
United States Naval Medical Center, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COLIC focused on measuring Nitroglycerin, Biliary Colic, Cholelithiasis, Abdominal Pain.

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients with right upper quadrant abdominal pain of less than 24 hours' duration between ages 18 and 60 years of age will be offered treatment with sublingual nitroglycerin or placebo.

Exclusion Criteria: Patients with obstructive hypertrophic cardiomyopathy, pronounced hypovolemia, alcohol use in the last 8 hours, clinical intoxication, STEMI or presumed cardiac chest pain, inferior myocardial infarction with right ventricular involvement, raised intracranial pressure, cardiac tamponade and patients taking certain drugs for erectile dysfunction (phosphodiesterase inhibitors), pregnancy or with a known allergy to nitroglycerin will be excluded from the study. Patients unable to give consent will be excluded.

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Sites / Locations

  • Naval Medical Center San DiegoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Sublingual nitroglycerine

placebo

Arm Description

Sublingual nitroglycerine followed by pain assessment and if necessary second dose of sublingual nitroglycerine

sublingual placebo followed by pain assessment and if necessary second dose of sublingual placebo

Outcomes

Primary Outcome Measures

pain relief on visual analog scale
pain relief assesement at two and five minutes after medication or placebo with standard treatment if inadequate pain relief.

Secondary Outcome Measures

Full Information

First Posted
October 24, 2012
Last Updated
September 27, 2017
Sponsor
United States Naval Medical Center, San Diego
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1. Study Identification

Unique Protocol Identification Number
NCT01715220
Brief Title
Treatment of Suspected Cholelithiasis With Nitroglycerin
Official Title
Treatment of Suspected Cholelithiasis With Nitroglycerin: a Randomized, Prospective Double-blind Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 2014 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
March 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
United States Naval Medical Center, San Diego

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
ABSTRACT: Sublingual nitroglycerin has been advocated for the treatment of acute pain from suspected symptomatic cholelithiasis. There is, however, no clinical studies that validate its use. This study is designed to evaluate the efficacy of nitroglycerine in relieving acute pain of suspected biliary tract origin. Nitroglycerin is a potent smooth muscle relaxant used for biliary tract dilation during ERCP, (Chelly, J) and has been recommended for treatment of biliary colic based on anecdotal experience and small case reports. Nitroglycerin effect is a result of the nitric oxide component of the medication which acts as a smooth muscle relaxant in vascular, bronchial, esophageal and biliary smooth muscles. [McGowan(1936), Chelly (1979),Toyoyama (2001)] The typical dose of nitroglycerin is 0.4 mg given sublingually in pill form or, more recently, in a metered spray form. In a case series reported by Hassel (1993), positive response times ranged from 20 to 60 seconds with duration of action of two to twelve hours. Sublingual nitroglycerin is most commonly used for treatment of chest pain related to insufficient cardiac perfusion. It has also been noted to relieve the pain of esophageal spasms. Nitroglycerin has an excellent safety profile if used in patients with adequate pretreatment blood pressures. [Newberry (2005), Nitroglycerine (2011), Nitro (2011), Wolters (2009)] This study proposes to compare sublingual 0.4 mg doses of nitroglycerin to placebo for the initial treatment of acute pain from suspected symptomatic cholelithiasis
Detailed Description
General Approach: This study proposes to compare sublingual 0.4 mg doses of nitroglycerin to placebo for initial treatment for acute pain from suspected symptomatic cholelithiasis. Patients with right upper quadrant abdominal pain of less than 24 hour duration between ages 18 and 60 years of age will be offered treatment with sublingual nitroglycerin or placebo. Patients with obstructive hypertrophic cardiomyopathy, pronounced hypovolemia, STEMI or presumed cardiac chest pain, inferior myocardial infarction with right ventricular involvement, raised intracranial pressure, cardiac tamponade, and patients taking certain drugs for erectile dysfunction (phosphodiesterase inhibitors), pregnancy, or with a known allergy to nitroglycerin will be excluded from the study. 2. Methods: A convenience sample of patients presenting to the Emergency Department will be randomized to receive either sublingual 0.4 mg doses of nitroglycerin or placebo. Pain prior to and at two minutes and five minutes after medication administration will be assessed using a visual analog scale. The medication will be either a 0.4 mg dose of nitroglycerin or a placebo. If pain is not completely relieved within five minutes, a second dose will be administered after blood pressure assessment. If the pain is not completely relieved after an additional two minute and five minute assessment or the pain returns, it will be treated in the standard manner at the discretion of the treating Emergency Physician. Ancillary studies and other treatments will be at the discretion of the treating physician. The 0.4mg dose of nitro has been proven to be a safe and well tolerated dose when administered to our patient population in treatment of acute coronary syndrome or suspected angina. Our attending, resident, and nursing staff are very familiar with this dose, the potential side effects of the medication, and its administration procedure. Therefore, we believe that 0.4mg will be a optimal starting dose for enrollees in our study. 3. Retrovirology Research: None 4. Investigational Drugs/Devices/Biologics Research: None 5. Statistical Analysis: Demographic information, patient characteristics, assignment to experimental group, and visual analog pain scale data will be entered into a spreadsheet . Pain will be recorded per patients at 5 time points: 0, 2, 5, 7, and 10 minutes. Descriptive statistics will be presented in tables and graphs. Pain scale results will be analyzed by a two-way (2x5) repeated measures analysis of variance with interaction and post hoc multiple comparisons. The primary time pair to be tested will be the difference between treatment and placebo groups in pain reduction from 0 to 2 minutes. The planned sample size is 62, with 31 in the placebo group and 31 in the nitro group. The sample size was calculated with the aid of Dr Riffenburgh. He agrees with sample size suggested above. 6. Military Relevance / Operational Use, if any: Sublingual nitroglycerin is a standard AMAL list item for independent providers in most field and operational settings. Relief of biliary colic can significantly reduce the number of urgent medical evacuations for right upper quadrant pain. There is also no mental status degradation with the use of nitroglycerin, unlike the opioids commonly used to treat biliary colic.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COLIC, BILIARY TRACT DISEASES
Keywords
Nitroglycerin, Biliary Colic, Cholelithiasis, Abdominal Pain.

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
62 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sublingual nitroglycerine
Arm Type
Active Comparator
Arm Description
Sublingual nitroglycerine followed by pain assessment and if necessary second dose of sublingual nitroglycerine
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
sublingual placebo followed by pain assessment and if necessary second dose of sublingual placebo
Intervention Type
Drug
Intervention Name(s)
sublingual nitroglycerine
Other Intervention Name(s)
Nitrolingual
Intervention Description
A convenience sample of patients presenting to the Emergency Department will be randomized to receive either sublingual 0.4 mg doses of nitroglycerin or placebo. Pain prior to and at two minutes and five minutes after medication administration will be assessed using a visual analog scale. The medication will be either a 0.4 mg dose of nitroglycerin or a placebo. If pain is not completely relieved within five minutes, a second dose will be administered after blood pressure assessment. If the pain is not completely relieved after an additional two minute and five minute assessment or the pain returns, it will be treated in the standard manner at the discretion of the treating Emergency Physician
Primary Outcome Measure Information:
Title
pain relief on visual analog scale
Description
pain relief assesement at two and five minutes after medication or placebo with standard treatment if inadequate pain relief.
Time Frame
two and five minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with right upper quadrant abdominal pain of less than 24 hours' duration between ages 18 and 60 years of age will be offered treatment with sublingual nitroglycerin or placebo. Exclusion Criteria: Patients with obstructive hypertrophic cardiomyopathy, pronounced hypovolemia, alcohol use in the last 8 hours, clinical intoxication, STEMI or presumed cardiac chest pain, inferior myocardial infarction with right ventricular involvement, raised intracranial pressure, cardiac tamponade and patients taking certain drugs for erectile dysfunction (phosphodiesterase inhibitors), pregnancy or with a known allergy to nitroglycerin will be excluded from the study. Patients unable to give consent will be excluded. -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
steven j portouw, MD
Phone
619-532-8274
Email
steven.portouw@med.navy.mil
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven J Portouw, MD
Organizational Affiliation
United States Naval Medical Center, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
Naval Medical Center San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92134
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Treatment of Suspected Cholelithiasis With Nitroglycerin

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