| Registry | NCT02253524 |
|---|---|
| Status | Completed |
| Phase | Phase 4 |
| Study type | Interventional; randomized, factorial, masking: triple, treatment |
| Enrollment | 200 (Actual) |
| Sponsor | Pamukkale University (Other) |
| Conditions | Nausea, Vomiting, Vertigo |
| Interventions | Dimenhydrinate, Metoclopramide (Drug) |
| Dates | start 2012-11-01, primary completion 2013-05-01, completion 2013-05-01, first posted 2014-10-01, last updated 2014-10-01 |
Related Papers Related Patents Related Grants Related Experts
All trials for Nausea All trials for Vomiting All trials of Dimenhydrinate All trials of Metoclopramide
* Vertigo complaint is one of the common cause of patients who applied to emergency services.
* Patients who have applied to emergency services with vertigo complaint mostly have nausea as an additionally symptom to this complaint and anti-emetic agents can be used in their treatments very often.
* The investigators purpose is to investigate the advantages of Dimenhydrinate and metoclopramide to each other in the treatment of vertigo and the vertigo accompanied by nausea
* Vertigo describes the illusion of being subject to an involuntary movement, usually rotational, of the patient or the patient's surroundings which is caused by sudden tonic neural activity.
* The management and episodic treatment of patients with spontaneous vertigo related nausea-vomiting symptoms are somewhat controversial in the emergency department setting.
* Patients admitted to the emergency department with complaints of vertigo in addition to a large portion of the symptoms are accompanied by nausea and antiemetic agents are frequently used in the treatment.
* An ideal treatment should be rapid in onset and effective, and lack debilitating side effects.
* Although a wide variety of classes of pharmacologic agents and modalities are used, the emergency department treatment of acute spontaneous vertigo and associated with nausea- vomiting has not been well studied.
* It has been reported that the most commonly used medications for parenteral treatment of vertigo and nausea-vomiting in emergency department are dimenhydrinate (DMT) and metoclopramide (MTP).
* It has a depressant action on hyper-stimulated labyrinthine function and antiemetic effects, believed to be due to the antihistamine.
* Dimenhydrinate inhibits vomiting by affecting the histaminic receptor and cholinergic receptor function center of vestibular nucleus in the central vestibular system.
* Dimenhydrinate reduces the symptoms of vertigo with depressant effects on the labyrinth function by this means.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Dimenhydrinate | Active comparator | Drug: Dimenhydrinate | 50 mg Dimenhydrinate with 5 cc syringe in 150 ml normal saline given as a slow intravenous infusion over 15 minutes |
| Metoclopramide | Active comparator | Drug: Metoclopramide | 10 mg Metoclopramide with 5 cc syringe in 150 ml normal saline given as a slow intravenous infusion over 15 minutes |
Sex: All, ages: 18 Years to 65 Years
Inclusion Criteria: * between 18 to 65 years old patients, * had vertigo and accompanied nausea or vomiting \[VAS (visual analog scale) score >5\] during their emergency department episode of care for which the attending physician recommended intravenous antiemetic medication. Exclusion Criteria: * abnormal vital signs, * women who were pregnant or lactation, * those with a history of epilepsy, * acute psychiatric symptoms, * organic brain disease, * parkinson's disease or phaeochromocytoma, * or any known allergy to the study drugs, * uncooperative individuals, * use of any antiemetic drug in the previous 8 hours or previous delivery of intravenous fluids during the emergency department episode of care, * currently undergoing chemotherapy or radiotherapy, * mechanical obstruction or perforation, * gastrointestinal bleeding, * inability to understand study explanation or outcome measures (any reason), * known allergy or previous adverse reaction to metoclopramide or dimenhydrinate, * and patients who refused to participate study.