Recruiting
Phase 2

Nitroglycerin

Sponsor:

United States Naval Medical Center, San Diego

Code:

NCT01715220

Conditions

COLIC

BILIARY TRACT DISEASES

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Interventions

sublingual nitroglycerine

Study Details

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

Conditions

COLIC

BILIARY TRACT DISEASES

Study ID

NCT01715220

Start date

Oct, 2014

Status verified date

Sep, 2017

Completion date

Mar, 2019

Anticipated

Primary completion date

Dec, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

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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Study Design

Enrollment

62 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Sublingual nitroglycerine

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

placebo comparator: placebo

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

Interventions

sublingual nitroglycerine

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

  • pain relief on visual analog scale [ Time Frame: two and five minutes ]

Central Contacts and Locations

Central contacts

Locations

Naval Medical Center San Diego

Recruiting

San Diego, California, United States, 92134

More Information

Sponsor

United States Naval Medical Center, San Diego

Last update posted

Sep 29, 2017

Last verified

Sep, 2017

Keywords

  • Nitroglycerin
  • Biliary Colic
  • Cholelithiasis
  • Abdominal Pain.

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by United States Naval Medical Center, San Diego on 2017-09-29.