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The goal of this clinical trial is to compare the efficacy of hypertonic saline nebulization with adrenaline nebulization in the treatment of acute bronchiolitis in children. Main aim is to evaluate the following in both group of patients
This is a double-blind clinical trial that will include all admitted patients with acute bronchiolitis, meeting inclusion criteria, admitted in Pediatrics department Combined Military Hospital Nowshera. Patients will be divided into two groups randomly. Group I patients will be nebulized with drug adrenaline every 6 hours and group II patients will be nebulized with hypertonic saline every 6 hours. After 24 hours and 48 hours of nebulization, researchers will record WDF score by measuring respiratory rate, heart rate, chest retractions, chest auscultation findings and SPO₂ levels. All data will be recorded on a research Performa including length of hospital stay. Data will be entered on SPSS to calculate results. Independent sample t-test was used to measure the effect of two drugs on the length of hospital stay and improvement of respiratory score with a 95% confidence interval. P value less than 0.05 will be considered as significant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypertonic saline nebulization group | Active Comparator | First group of patients diagnosed as acute bronchiolitis will be nebulized with hypertonic saline every 6 hours and data will be recorded on a Performa |
|
| Adrenaline nebulization group | Active Comparator | Second group of patients will be nebulized with adrenaline every 6 hours and data will be recorded on a Performa |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypertonic Saline Solution, 1 Ml | Drug | Dilute 0.3 ml hypertonic saline with 3 ml normal saline for nebulization |
|
| Measure | Description | Time Frame |
|---|---|---|
| Wood-Downes-Ferres clinical score calculation | A score of 0-3 mild, 4-6 moderately ill, >6 severely ill | at 24 and 48 hours of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| total length of hospitalization | less than 1 week, more than 1 week, | less than 7 days, 7-10 days, 10-14 days |
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Inclusion Criteria:
Exclusion Criteria:
children with co-exiting illnesses like
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Syed Qamar Zaman | Contact | 00923365307823 | dr.qamarzaman@hotmail.com | |
| Madeeha Qamar | Contact | 00923353459662 | affifamadhu89@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Prof Shahid Mahmud | Military Hospital Rawalpindi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Combined Military Hospital | Recruiting | Nowshera | KPK | 24110 | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25452661 | Result | Piedimonte G, Perez MK. Respiratory syncytial virus infection and bronchiolitis. Pediatr Rev. 2014 Dec;35(12):519-30. doi: 10.1542/pir.35-12-519. No abstract available. | |
| 19953579 | Result | Anil AB, Anil M, Saglam AB, Cetin N, Bal A, Aksu N. High volume normal saline alone is as effective as nebulized salbutamol-normal saline, epinephrine-normal saline, and 3% saline in mild bronchiolitis. Pediatr Pulmonol. 2010 Jan;45(1):41-7. doi: 10.1002/ppul.21108. |
| Label | URL |
|---|---|
| RCTnebulized epinephrine versus nebulized hypertonic saline in infants with acute bronchiolitis | View source |
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After informed consent of participants and ethical committee approval, it will be shared.
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| ID | Term |
|---|---|
| D012462 | Saline Solution, Hypertonic |
| D004837 | Epinephrine |
| ID | Term |
|---|---|
| D006982 | Hypertonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D004983 | Ethanolamines |
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Patients with acute bronchiolitis after informed written consent will be divided into two groups randomly. Group I will be nebulized with adrenaline every 6 hours and group II will nebulized with hypertonic saline every 6 hours. After 24 hours and 48 hours of nebulization, WDF score will be recorded by measuring respiratory rate, heart rate, chest retractions, chest auscultation findings and SPO₂ levels. Researcher will record all data on a specified Performa.
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Investigator will make all the protocol and research Performa. Drugs will already be prepared for nebulization and labelled by investigator. Researcher /care provider will nebulize the patients of both groups randomly and record the results accordingly.
| Adrenaline | Drug | dilute 0.3 ml adrenaline with 3 ml normal saline for nebulization |
|
|
| 27549684 | Result | Florin TA, Plint AC, Zorc JJ. Viral bronchiolitis. Lancet. 2017 Jan 14;389(10065):211-224. doi: 10.1016/S0140-6736(16)30951-5. Epub 2016 Aug 20. |
| 19884591 | Result | Grewal S, Ali S, McConnell DW, Vandermeer B, Klassen TP. A randomized trial of nebulized 3% hypertonic saline with epinephrine in the treatment of acute bronchiolitis in the emergency department. Arch Pediatr Adolesc Med. 2009 Nov;163(11):1007-12. doi: 10.1001/archpediatrics.2009.196. |
| 29265171 | Result | Zhang L, Mendoza-Sassi RA, Wainwright C, Klassen TP. Nebulised hypertonic saline solution for acute bronchiolitis in infants. Cochrane Database Syst Rev. 2017 Dec 21;12(12):CD006458. doi: 10.1002/14651858.CD006458.pub4. |
| 12675760 | Result | Hariprakash S, Alexander J, Carroll W, Ramesh P, Randell T, Turnbull F, Lenney W. Randomized controlled trial of nebulized adrenaline in acute bronchiolitis. Pediatr Allergy Immunol. 2003 Apr;14(2):134-9. doi: 10.1034/j.1399-3038.2003.00014.x. |
| 28470580 | Result | Fretzayas A, Moustaki M. Etiology and clinical features of viral bronchiolitis in infancy. World J Pediatr. 2017 Aug;13(4):293-299. doi: 10.1007/s12519-017-0031-8. Epub 2017 May 4. |
| Viral bronchiolitis in children: A common condition with few therapeutic options | View source |
| D000605 |
| Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |