## Protocol Section
### Identification Module
**NCT ID:** NCT02056379

**Acronym:** BUDEXA

**Brief Title:** Comparison Between Budesonide and Dexamethasone Treatments for Respiratory Discomfort After Extubation on Children

**Official Title:** Comparison Between Inhaled Budesonide and Intravenous Dexamethasone Treatments for Postextubation Stridor in Children

#### Organization Study ID Info
**ID:** 508177
#### Organization
**Class:** OTHER
**Full Name:** Hospital Israelita Albert Einstein
### Status Module
#### Completion Date
**Date:** 2016-03

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** NOT_YET_RECRUITING
#### Last Update Post Date
**Date:** 2014-02-06

**Type:** ESTIMATED

**Last Update Submit Date:** 2014-02-04

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2015-03

**Type:** ESTIMATED

#### Start Date
**Date:** 2014-03

**Status Verified Date:** 2014-02

#### Study First Post Date
**Date:** 2014-02-06
**Type:** ESTIMATED
**Study First Submit Date:** 2014-01-23
**Study First Submit QC Date:** 2014-02-04
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Hospital M'Boi Mirim

#### Lead Sponsor

**Class:** OTHER

**Name:** Hospital Israelita Albert Einstein

#### Responsible Party

**Investigator Affiliation:** Hospital Israelita Albert Einstein

**Investigator Full Name:** Daniela Nasu Monteiro Medeiros

**Investigator Title:** MD

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The study aims to analyze and compare the clinical effects of using inhaled budesonide or intravenous dexamethasone in the treatment of postextubation stridor on children admitted to the pediatric intensive care units at Hospital Municipal do M´Boi Mirim and Hospital Albert Einstein.

**Detailed Description:** The investigators propose to perform a prospective, randomized, controlled and double-blind non inferiority study enrolling 70 children with postextubation stridor. The population will be divided in two groups: group 1 will receive inhaled budesonide and IV NS (intravenous normal saline) and group 2 will receive IV (intravenous) dexamethasone and inhaled normal saline. The study aims to analyze and compare (I would just say compare) the clinical effects of using inhaled budesonide or IV dexamethasone in the treatment of postextubation stridor on children admitted to the pediatric intensive care units at Hospital Municipal do M´Boi Mirim and Hospital Albert Einstein.

### Conditions Module

**Conditions:**

- Stridor

**Keywords:**

- stridor

- laryngitis

- budesonide

- dexamethasone

- children

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 70

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 2 mg of nebulized budesonide at 12/12 hours and 8 cc of intravenous normal saline.

**Intervention Names:**

- Drug: Budesonide

**Label:** Budesonide

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** This group will receive 0,15 mg/kg/dose of intravenous dexamethasone at 6/6 hours and 8 cc of nebulized normal saline at 12/12 hours.

**Intervention Names:**

- Drug: Dexamethasone

**Label:** Dexamethasone

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Budesonide

**Description:** The subjects will receive a 5 ml normal saline inhalation right after extubation and will be re-evaluated in 5 to 10 minutes. The ones who develop upper airway obstruction and stridor with a Downes-Raphaelly score of 2 or higher will receive 0.5 ml/kg of inhaled epinephrine 1:1000 diluted to a final volume of 5 ml with a maximum dose of 2.5 ml in children up to 4 years and 5 ml in children with 5 years and above, as recommended by the American Academy of Pediatrics. The subjects who do not show an improvement after the epinephrine treatment will then be randomized to receive 2 mg of inhaled budesonide and 3 ml of IV normal saline. If there is an improvement the following maintenance therapy will be instituted for 48 hs and the subjects will receive 2 mg of budesonide q12hs and 3 ml of IV NS q6hs.

**Name:** Budesonide

**Other Names:**

- Pulmicort

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Dexamethasone

**Description:** The subjects will receive a 5 ml normal saline inhalation right after extubation and will be re-evaluated in 5 to 10 minutes. The ones who develop upper airway obstruction and stridor with a Downes-Raphaelly score of 2 or higher will receive 0.5 ml/kg of inhaled epinephrine 1:1000 diluted to a final volume of 5 ml with a maximum dose of 2.5 ml in children up to 4 years and 5 ml in children with 5 years and above, as recommended by the American Academy of Pediatrics. The subjects who do not show an improvement after the epinephrine treatment will then be randomized to receive 8 ml of inhaled normal saline and 0.6 mg/kg of IV dexamethasone. The dexamethasone group will receive 8 ml of inhaled NS q12hs and 0.15 mg/kg/dose of dexamethasone q6hs.

**Name:** Dexamethasone

**Other Names:**

- Decadron, Hexadrol, Maxidex

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** The investigators will use the Downes-Raphaelly score as an objective measurement tool of degree of respiratory discomfort. The decrease of Downes-Raphaelly score will be considered as an improvement of patient condition.

**Measure:** The decrease of stridor and respiratory discomfort

**Time Frame:** 6 hours

#### Secondary Outcomes

**Description:** The investigators will consider hypertension, hyperglycemia, gastrointestinal hemorrhage as adverse events of the usage of dexamethasone.

**Measure:** Number of patients with adverse events

**Time Frame:** 1 day

**Description:** The investigators will study if budesonide has the same time frame improvement treating stridor and respiratory discomfort.

**Measure:** The time frame of stridor's and respiratory discomfort's improvements

**Time Frame:** 1 hour

**Description:** Extubation failure will be considered as a need for re-intubation during de 48 hours after extubation.

**Measure:** The number of patients that will have extubation failure at each arm

**Time Frame:** 2 days

**Description:** The inhaled epinephrine will be used as rescue therapy to absence of improvement. The number of inhaled epinephrine dosage used on each patient will be a measure of efficacy of budesonide or dexamethasone.

**Measure:** The number of inhaled epinephrine doses used in each arms.

**Time Frame:** 2 days

**Description:** The non invasive mechanical ventilation and Heliox are rescue therapies. The number of patients treated with those rescue therapies will be a measure of efficacy of budesonide or dexamethasone.

**Measure:** The number of patients who need for non invasive mechanical ventilation or Heliox

**Time Frame:** 2 days

**Description:** The bronchoscopy will demonstrate the non-inflammatory causes of stridor, such as: vocal cord paralysis, granuloma formation, subglottic stenosis, cricoarytenoid joint disfunction. In these cases, neither dexamethasone nor budesonide will improve clinical conditions.

**Measure:** The numbers of bronchoscopies

**Time Frame:** 2 days

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* patients intubated for periods longer than 24hs
* age between 28 days and than 15 years
* post extubation stridor must be clinically diagnosticated by a MD
* informed consent must be obtained

Exclusion Criteria:

* patients under palliative care
* presence of neuromuscular disease
* previous airway pathologies
* epiglottitis, aspiration of foreign bodies
* viral laryngitis
* former airway surgery
* patients previously included in the study within the same hospital admission
* corticosteroid use in the 48hs preceding extubation

**Maximum Age:** 19 Years

**Minimum Age:** 1 Month

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** daninasu@yahoo.com.br

**Name:** Daniela NM Medeiros

**Phone:** 5511973347555

**Role:** CONTACT

**Contact 2:**

**Email:** troster@einstein.br

**Name:** Eduardo J Troster

**Phone:** 551121511233

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** São Paulo

**Contacts:**

***Contact 1:***

- **Email:** daninasu@yahoo.com.br

- **Name:** Daniela NM Medeiros

- **Phone:** 5511873347555

- **Role:** CONTACT

***Contact 2:***

- **Email:** troster@einstein.br

- **Name:** Eduardo J Troster

- **Phone:** 551121511233

- **Role:** CONTACT

**Country:** Brazil

**Facility:** Instituto Israelita de Ensino e Pesquisa Albert Einstein 's (IIEP)

**Zip:** 05652-000

#### Overall Officials

**Official 1:**

**Affiliation:** Hospital Israelita Albert Einstein

**Name:** Daniela NM Medeiros

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**Citation:** Klassen TP, Feldman ME, Watters LK, Sutcliffe T, Rowe PC. Nebulized budesonide for children with mild-to-moderate croup. N Engl J Med. 1994 Aug 4;331(5):285-9. doi: 10.1056/NEJM199408043310501.

**PMID:** 8022437

**Citation:** Johnson DW, Jacobson S, Edney PC, Hadfield P, Mundy ME, Schuh S. A comparison of nebulized budesonide, intramuscular dexamethasone, and placebo for moderately severe croup. N Engl J Med. 1998 Aug 20;339(8):498-503. doi: 10.1056/NEJM199808203390802.

**PMID:** 9709042

**Citation:** Geelhoed GC, Macdonald WB. Oral and inhaled steroids in croup: a randomized, placebo-controlled trial. Pediatr Pulmonol. 1995 Dec;20(6):355-61. doi: 10.1002/ppul.1950200604.

**PMID:** 8649914

**Citation:** Sinha A, Jayashree M, Singhi S. Aerosolized L-epinephrine vs budesonide for post extubation stridor: a randomized controlled trial. Indian Pediatr. 2010 Apr;47(4):317-22. doi: 10.1007/s13312-010-0060-z. Epub 2009 Sep 3.

**PMID:** 19736368

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012818

- Term: Signs and Symptoms, Respiratory

### Condition Browse Module - Browse Branches

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC01

- Name: Infections

- Abbrev: BC09

- Name: Ear, Nose, and Throat Diseases

### Condition Browse Module - Browse Leaves

- ID: M27137

- Name: Respiratory Aspiration

- Relevance: LOW

- As Found: Unknown

- ID: M10843

- Name: Laryngitis

- Relevance: LOW

- As Found: Unknown

- ID: M6653

- Name: Croup

- Relevance: LOW

- As Found: Unknown

- ID: M14972

- Name: Respiratory Sounds

- Relevance: HIGH

- As Found: Stridor

- ID: M15623

- Name: Signs and Symptoms, Respiratory

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000012135

- Term: Respiratory Sounds

### Intervention Browse Module - Ancestors

- ID: D000000893

- Term: Anti-Inflammatory Agents

- ID: D000000932

- Term: Antiemetics

- ID: D000001337

- Term: Autonomic Agents

- ID: D000018373

- Term: Peripheral Nervous System Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000005765

- Term: Gastrointestinal Agents

- ID: D000005938

- Term: Glucocorticoids

- ID: D000006728

- Term: Hormones

- ID: D000006730

- Term: Hormones, Hormone Substitutes, and Hormone Antagonists

- ID: D000018931

- Term: Antineoplastic Agents, Hormonal

- ID: D000000970

- Term: Antineoplastic Agents

- ID: D000001993

- Term: Bronchodilator Agents

- ID: D000018927

- Term: Anti-Asthmatic Agents

- ID: D000019141

- Term: Respiratory System Agents

### Intervention Browse Module - Browse Branches

- Abbrev: Infl

- Name: Anti-Inflammatory Agents

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: AnEm

- Name: Antiemetics

- Abbrev: Gast

- Name: Gastrointestinal Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Resp

- Name: Respiratory System Agents

- Abbrev: VaCoAg

- Name: Vasoconstrictor Agents

### Intervention Browse Module - Browse Leaves

- ID: M7102

- Name: Dexamethasone

- Relevance: HIGH

- As Found: Children

- ID: M21711

- Name: Budesonide

- Relevance: HIGH

- As Found: Laboratory

- ID: M7992

- Name: Epinephrine

- Relevance: LOW

- As Found: Unknown

- ID: M235549

- Name: Dexamethasone acetate

- Relevance: LOW

- As Found: Unknown

- ID: M199152

- Name: BB 1101

- Relevance: LOW

- As Found: Unknown

- ID: M30371

- Name: Racepinephrine

- Relevance: LOW

- As Found: Unknown

- ID: M211043

- Name: Epinephryl borate

- Relevance: LOW

- As Found: Unknown

- ID: M4217

- Name: Anti-Inflammatory Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4251

- Name: Antiemetics

- Relevance: LOW

- As Found: Unknown

- ID: M8881

- Name: Gastrointestinal Agents

- Relevance: LOW

- As Found: Unknown

- ID: M9047

- Name: Glucocorticoids

- Relevance: LOW

- As Found: Unknown

- ID: M9789

- Name: Hormones

- Relevance: LOW

- As Found: Unknown

- ID: M9788

- Name: Hormone Antagonists

- Relevance: LOW

- As Found: Unknown

- ID: M20966

- Name: Antineoplastic Agents, Hormonal

- Relevance: LOW

- As Found: Unknown

- ID: M5269

- Name: Bronchodilator Agents

- Relevance: LOW

- As Found: Unknown

- ID: M20963

- Name: Anti-Asthmatic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M21137

- Name: Respiratory System Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000003907

- Term: Dexamethasone

- ID: D000019819

- Term: Budesonide

### Misc Info Module

- Version Holder: 2024-05-24
