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Inapsine (Droperidol) - Summary



Cases of QT prolongation and/or torsade de pointes have been reported in patients receiving INAPSINE at doses at or below recommended doses. Some cases have occurred in patients with no known risk factors for QT prolongation and some cases have been fatal.

Due to its potential for serious proarrhythmic effects and death, INAPSINE should be reserved for use in the treatment of patients who fail to show an acceptable response to other adequate treatments, either because of insufficient effectiveness or the inability to achieve an effective dose due to intolerable adverse effects from those drugs (see Warnings, Adverse Reactions, Contraindications, and Precautions).

Cases of QT prolongation and serious arrhythmias (e.g., torsade de pointes) have been reported in patients treated with INAPSINE. Based on these reports, all patients should undergo a 12-lead ECG prior to administration of INAPSINE to determine if a prolonged QT interval (i.e., QTc greater than 440 msec for males or 450 msec for females) is present. If there is a prolonged QT interval, INAPSINE should NOT be administered. For patients in whom the potential benefit of INAPSINE treatment is felt to outweigh the risks of potentially serious arrhythmias, ECG monitoring should be performed prior to treatment and continued for 2 to 3 hours after completing treatment to monitor for arrhythmias.

INAPSINE is contraindicated in patients with known or suspected QT prolongation, including patients with congenital long QT syndrome.

INAPSINE should be administered with extreme caution to patients who may be at risk for development of prolonged QT syndrome (e.g., congestive heart failure, bradycardia, use of a diuretic, cardiac hypertrophy, hypokalemia, hypomagnesemia, or administration of other drugs known to increase the QT interval). Other risk factors may include age over 65 years, alcohol abuse, and use of agents such as benzodiazepines, volatile anesthetics, and IV opiates. Droperidol should be initiated at a low dose and adjusted upward, with caution, as needed to achieve the desired effect.



INAPSINE contains droperidol, a neuroleptic (tranquilizer) agent.

INAPSINE (droperidol) is indicated to reduce the incidence of nausea and vomiting associated with surgical and diagnostic procedures.

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Media Articles Related to Inapsine (Droperidol)

Nausea and Vomiting (Causes, Natural Remedies, Diet, Medication)
Source: MedicineNet Anaphylaxis Specialty [2017.07.19]
Title: Nausea and Vomiting (Causes, Natural Remedies, Diet, Medication)
Category: Diseases and Conditions
Created: 1/31/2005 12:00:00 AM
Last Editorial Review: 7/19/2017 12:00:00 AM

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Published Studies Related to Inapsine (Droperidol)

Intravenous droperidol or olanzapine as an adjunct to midazolam for the acutely agitated patient: a multicenter, randomized, double-blind, placebo-controlled clinical trial. [2013]
rapid patient sedation... CONCLUSION: Intravenous droperidol or olanzapine as an adjunct to midazolam is

[Preoperative intravenous administration of droperidol (1.25 mg) reduced postoperative nausea and vomiting after intrathecal morphine administration]. [2011.02]
BACKGROUND: Intrathecal morphine (ITM) is an excellent postoperative analgesic, but may often cause postoperative nausea and vomiting (PONV). We designed this prospective, randomized and controlled study to evaluate the antiemetic efficacy of low-dose droperidol for the treatment of PONV caused by ITM... CONCLUSIONS: Single intravenous administration of 1.25 mg droperidol before operation showed prophylactic efficacy in early PONV caused by ITM. The duration of droperidol action was shorter than that of ITM. Hence we recommend that droperidol should be administered more frequently or continuously in the postoperative period.

A randomized comparison of droperidol, metoclopramide, tropisetron, and ondansetron for the prevention of postoperative nausea and vomiting. [2011]
BACKGROUND: Nausea and vomiting are the most common causes of postoperative complications, and they are seen most often after operations performed using general anesthesia and sedation. We designed this study to compare the effects of droperidol, metoclopramide, tropisetron, and ondansetron for the prevention of postoperative nausea and vomiting in patients undergoing gynecologic operations... CONCLUSION: We conclude that metoclopramide is not effective in preventing postoperative nausea and vomiting after gynecologic operations. Droperidol, tropisetron, and ondansetron are effective; however, the sedating effects of droperidol and tropisetron should be considered. Copyright (c) 2010 S. Karger AG, Basel.

Randomized controlled trial of intramuscular droperidol versus midazolam for violence and acute behavioral disturbance: the DORM study. [2010.10]
STUDY OBJECTIVE: We determine whether droperidol, midazolam, or the combination is more effective for intramuscular sedation in violent and acute behavioral disturbance in the emergency department (ED)... CONCLUSION: Intramuscular droperidol and midazolam resulted in a similar duration of violent and acute behavioral disturbance, but more additional sedation was required with midazolam. Midazolam caused more adverse effects because of oversedation, and there was no evidence of QT prolongation associated with droperidol compared with midazolam. Copyright (c) 2010 American College of Emergency Physicians. Published by Mosby, Inc. All rights reserved.

Comparison between ketamine and fentanyl-droperidol for rectal premedication in children: a randomized placebo controlled trial. [2010.04]
PURPOSE: A common concern of anesthesiologists is the management of children involved in stressful scenarios, and premedication is considered, in most situations, as useful to reduce the stress responses. This randomized placebo-controlled study was designed to evaluate two premedicants, ketamine versus a combination of fentanyl-droperidol, rectally administered, in pediatric surgical outpatients... CONCLUSION: In this study, premedication with rectal ketamine showed significantly better overall results in the preoperative period than premedication with either fentanyl-droperidol or placebo.

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Clinical Trials Related to Inapsine (Droperidol)

The Effects of the Anti Nausea Drugs Droperidol and Ondansetron on the Way the Heart Recovers Between Beats [Completed]
We are investigating a new technique for testing the effect of drugs on electrical activity in the heart. Disturbances of this electrical activity can cause life-threatening changes to heart rhythms. A better way of measuring the risk has recently been developed, and our research team leads the world in using this tool to test the safety of drugs used in children. Children and their families want to know that the drugs being used are safe, as do the doctors that care for them. In this study, we will take heartbeat tracings (ECGs) from 60 children before and during their operations. The ECGs will then be checked by a children's heart specialist. Differences on the ECGs will be related to the presence and amount of drug (droperidol or ondansetron) given. We expect that the droperidol or ondansetron will not cause any changes that show increased risk of abnormal heart rhythms. We can then tell patients, parents and regulatory authorities of the safety profile of this aspect of the drug; moreover, the study can be used as a model for testing many other drugs used in hospitals.

Evaluation of 2 Doses of Intravenous Droperidol in the Prevention of Postoperative Nausea [Terminated]
In this prospective, randomised, placebo-controlled study, the researchers determined whether 0. 625 mg or 2. 5 mg of IV droperidol given 30 min before emergence from general anaesthesia reduces the incidence of immediate and delayed post operative nausea and vomiting (PONV) in thyroid surgical female population. Two hundred and forty six female patients receiving general anaesthesia for thyroid surgery received either droperidol 0. 625 mg or droperidol 2. 5 mg or placebo before emergence.

Role of Droperidol in Postoperative Vomiting [Completed]
Protocol title: Role of low dose droperidol in postoperative vomiting Purpose: Evaluate the efficacy of droperidol to postoperative nausea and vomiting when administrated at the introduction to anesthesia, prior to surgery Design: Prospective, randomized, placebo-controlled study Patient Population: Male or female subjects 18 years of age or older who are scheduled for laparoscopic cholecystectomy No. of Subjects: 100 patients divided into two groups, estimated up to 6 months to enroll Duration of Treatment: Prior operation Duration of Follow-up: Follow-up will be performed for 24 hours postoperatively Endpoints: To evaluate the effectiveness of low dose droperidol when administered Prior surgery

Droperidol Versus Metoclopramide for the Treatment of Primary Headaches [Terminated]

Postoperative Vomiting in Children: Comparison Tri - Versus bi -Prophylaxis [Completed]
The purpose of this study is to evaluate the benefit of addition of droperidol to prophylaxis with ondansetron and dexamethasone in children with high risk of postoperative vomiting (POV). In adults some authors showed that the effectiveness of prophylaxis is correlated to the number of molecules or specific procedures used.

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Page last updated: 2017-07-19

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