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A Randomized Double-Blind, Multi-Dose, Placebo Controlled Study of Acetaminophen Injection Post Surgical Dental Pain

2019-07-18 10:31:11 | BioPortfolio

Summary

To assess the safety, tolerability, analgesic, efficacy and pharmacokinetics of acetaminophen 1300mg (IV APAP) dosed every eight hours relative to placebo and acetaminophen 1000mg (IV APAP) dosed every 6 hours relative to placebo over a 24 hour period in patient experiencing moderate to server pain following the surgical removal of third molar.

Description

This will be a randomized, double-blind, single-site, placebo-controlled, parallel-group study to assess similarities in safety, tolerability, efficacy, and pharmacokinetics of 1300 mg of injectable acetaminophen given in three doses, each 8 hours apart, relative to placebo, and 1000 mg of injectable acetaminophen given in four doses, each 6 hours apart, relative to placebo over a 24-hour period in patients experiencing moderate to severe postsurgical pain within 7 hours following surgical removal of 2 or more molars

Study Design

Conditions

Pain, Postoperative

Intervention

Ofirmev Injectable Product (Acetaminophen), Placebo

Location

JBR
Salt Lake City
Utah
United States
84107

Status

Recruiting

Source

Nevakar, LLC

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-07-18T10:31:11-0400

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Medical and Biotech [MESH] Definitions

A nonsteroidal anti-inflammatory agent with potent analgesic and antiarthritic properties. It has been shown to be effective in the treatment of OSTEOARTHRITIS; RHEUMATOID ARTHRITIS; ankylosing SPONDYLITIS; and in the alleviation of postoperative pain (PAIN, POSTOPERATIVE).

Pain during the period after surgery.

A narcotic analgesic that can be used for the relief of most types of moderate to severe pain, including postoperative pain and the pain of labor. Prolonged use may lead to dependence of the morphine type; withdrawal symptoms appear more rapidly than with morphine and are of shorter duration.

Abdominal symptoms after removal of the GALLBLADDER. The common postoperative symptoms are often the same as those present before the operation, such as COLIC, bloating, NAUSEA, and VOMITING. There is pain on palpation of the right upper quadrant and sometimes JAUNDICE. The term is often used, inaccurately, to describe such postoperative symptoms not due to gallbladder removal.

Relief of PAIN, without loss of CONSCIOUSNESS, through ANALGESIC AGENTS administered by the patients. It has been used successfully to control POSTOPERATIVE PAIN, during OBSTETRIC LABOR, after BURNS, and in TERMINAL CARE. The choice of agent, dose, and lockout interval greatly influence effectiveness. The potential for overdose can be minimized by combining small bolus doses with a mandatory interval between successive doses (lockout interval).

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