Epinephrine, Dexamethasone and Hypertonic Saline in Bronchiolitis
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT02585531 |
|
Recruitment Status : Unknown
Verified October 2015 by Hospital General Naval de Alta Especialidad - Escuela Medico Naval.
Recruitment status was: Not yet recruiting
First Posted : October 23, 2015
Last Update Posted : November 11, 2015
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Bronchiolitis is one of the main reasons for consultation in primary care and emergency services, as well as the leading cause of hospitalization for lower respiratory tract infection in children under two years. There is still no consensus on the medical management of the disease, in clinical practice there is wide variability in the treatment with inhaled drugs and / or oral bronchodilators, steroids, antihistamines despite the viral etiology of the disease, which results in increased morbidity and a major economic benefit for all health services.
Several studies are in relation to the management of bronchiolitis, one of which was made during 2014 in the Naval Hospital of High Specialty which included 90 participants comparing 3 treatment. The treatments administered were: dexamethasone and epinephrine (Levogira) (ED), hypertonic saline 3% (SSH 3%)and saline 0.9% ( SS 0.9%), finding that the handling of ED and SSH 3% had lower rates of hospital admissions compared to the symptomatic management of SS 0.9%. Although the superiority of SSH3% and ED in relation to the use of SS 0.9% was demonstrated, it was not possible to establish difference statistically significant between them. Why it was considered necessary to continue the study focused on determining the difference in the effectiveness of ED and SSH 3%. Therefore, the purpose of this investigation is to determine whether there is a difference between the use of dexamethasone and epinephrine versus hypertonic saline (3%).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Bronchiolitis | Drug: Hypertonic Saline 3% Drug: Epinephrine and Dexamethasone | Phase 2 |
Respiratory tract infections are one of the leading causes of consultation in the Hospital General Naval de Alta Especialidad, in the emergency department and outpatient. Only in the last year (2014) shows that a total of 2690 pediatric consultations were provided in the emergency department, 1000 of them were for respiratory tract infections, constituting an approximate percentage of 37%. This figure increased over the previous year (2013) in which emergency visits corresponding 1130 290 cases consultations with boxes airways getting a percentage of 25% is given.
Due to the high incidence of lower respiratory tract infections among patients in the pediatric ward, specifically for infants under two patients; early diagnosis of acute bronchiolitis is essential to initiate proper management without falling into the overuse of drugs that have not shown adequate results.
In the last five years it has seen an increase in cases of bronchiolitis treated in both outpatient or emergency department of the Naval General Hospital. Given these data, a priority for a reason and consensus of treatment for patients with bronchiolitis.
Faced with these alarming epidemiological data both nationally and globally, it is difficult to understand that there is no consensus on the management of this entity. Although mortality is low, it represents a high cost for society and especially for health institutions, represented by a high rate of income, empirical treatments and other logistical issues.
This document intends to obtain evidence of better treatment in the population in order to establish an optimal management without spilling resources would reduce the rate of hospital admissions, first to the Naval General Hospital of High Specialty and then unify all Naval Health centers.
All this, on a solid foundation of knowledge, with the latest revisions in the interest of the subject, in order to provide the best care to every patient. Among the treatments given in this research the application of adrenaline is included, its usefulness is based on the action that causes on alpha receptors causing vasoconstriction, decreased blood flow and inflammation, responsible for the obstruction which is part of the pathophysiology of bronchiolitis. During the investigation it was decided to use it in its natural form (Levogira) because it is less expensive and the investigators can find it in an accessible at other institutions. Studies comparing its use in relation to the racemic epinephrine, show no difference. In addition to reporting a power 30 times higher in relation to the racemic epinephrine.
The study is feasible because the drugs used in this study are within the basic framework of hospital drugs, which do not involve any cost or use of additional staff for the hospital.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 100 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Epinephrine, Dexamethasone, and Hypertonic Saline in Children With Bronchiolitis in the Hospital General Naval de Alta Especialidad. A Randomized Controlled Trial |
| Study Start Date : | November 2015 |
| Estimated Primary Completion Date : | February 2017 |
| Estimated Study Completion Date : | April 2017 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: HS3% group
Administration of nebulized hypertonic saline for 4 days. Hypertonic Saline 3% 3 ml.
|
Drug: Epinephrine and Dexamethasone
The treatment will be administered in the following order : First day: One treatment of nebulized dexamethasone 4mg (1ml of dexamethasone 8mg/2ml) + 3ml NS, followed by two treatments of nebulized epinephrine (3 ml of epinephrine in a 1:1000 solution per treatment) with interval 20 minutes Second to fourth day: One treatment of nebulized dexamethasone 4 mg (1ml of dexamethasone 8mg/2ml) + 3ml Normal saline 0.9%, every 24 hours. Other Name: ED |
|
Active Comparator: ED group
Administration of nebulized epinephrine and dexamethasone for 4 days. Epinephrine 1:1000 solution. Dexamethasone solution 8mg/2ml.
|
Drug: Hypertonic Saline 3%
The treatment will be administered in the following order : First day: 3 treatments of nebulized HS 3% 3ml of treatment with interval 20 minutes Second to fourth day: One treatment of nebulized HS 3% 3ml every 24 hours . Other Name: HS3% |
- Rate of hospital admissions [ Time Frame: 7 days after treatment ]Tracking each patient until 7 days after treatment to verify hospitalization rate.
- Respiration after treatment in the First Day. [ Time Frame: 20 minutes after administration of treatment. ]Breathing frequency after the application of nebulization in the First day of treatment (breath per minute).
- Heart rate after treatment in the First Day. [ Time Frame: 20 minutes after administration of treatment. ]Heart rate after the application of nebulization in the First day of treatment (beat per minute).
- Diastolic and Systolic blood pressure after treatment in the First Day. [ Time Frame: 20 minutes after administration of treatment. ]Diastolic and Systolic blood pressure after the application of nebulization in the First day of treatment (mmHg).
- Oxygen Saturation After after treatment in the First Day. [ Time Frame: 20 minutes after administration of treatment. ]Oxygen Saturation after the application of nebulization in the First day of treatment (%).
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 2 Months to 24 Months (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients under 2 years of age diagnosed with bronchiolitis
- Be beneficiaries Marine
- Outpatient
- Severity of Bronchiolitis mild to moderate scale according to Difficulty rating scale Respiratory (RDAI) for bronchiolitis (RDAI score 2-8).
Exclusion Criteria:
- Patients with a history of atopy
- Patients with a history of asthma in infants.
- Patients with comorbidity
- RDAI> 9 at diagnosis.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02585531
| Contact: Dra. Mayra Rubí Arcos Cruz, Pediatrician | (52) 55-28-300-519 | may03_05@hotmail.com |
| Mexico | |
| Hospital General Naval de Alta Especialidad | |
| México, Distrito Federal, Distrito Federal, Mexico, 04480 | |
| Principal Investigator: | Dra. Mayra Rubi Arcos Cruz, Pediatrician | Secretaria de Marina |
| Responsible Party: | Hospital General Naval de Alta Especialidad - Escuela Medico Naval |
| ClinicalTrials.gov Identifier: | NCT02585531 |
| Other Study ID Numbers: |
HGNAE 06 |
| First Posted: | October 23, 2015 Key Record Dates |
| Last Update Posted: | November 11, 2015 |
| Last Verified: | October 2015 |
|
Bronchiolitis Dexamethasone Epinephrine Hypertonic saline |
|
Bronchiolitis Bronchitis Respiratory Tract Infections Infections Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Dexamethasone Epinephrine Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic beta-Agonists Bronchodilator Agents Anti-Asthmatic Agents Respiratory System Agents |