The Effect of Nebulized Epinephrine in Asthma Exacerbation in Pediatric Age Group With the Standard Treatment Compared to Standard Treatment Using Improvement PRAM Score as a Primary Outcome
NCT05667727 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2025-06-06
Summary
Our study aiming to look in improvement of Pediatric Respiratory Assessment Measure (PRAM) score as a primary outcome. The secondary outcomes involving the need for second step management, need for admission and possible side effects.
It's double blinded randomized control study comparing Nebulized Epinephrine with standard treatment (salbutamol + Ipratropium) versus the standard treatment only in pediatric patient.
A pilot study will be conducted before to detect the sample size required and data will be collected at deferent interval post treatment targeting intension to treat for analysis.
Conditions
- Shortness of Breath
- Asthma in Children
- Epinephrine Causing Adverse Effects in Therapeutic Use
- Salbutamol Adverse Reaction
Interventions
- DRUG
-
nebulized epinephrine
we are using 1:1000 epinephrine into nebulization form
- DRUG
-
Salbutamol
Patient will receive salbutamol as 4th nebulization.
Sponsors & Collaborators
-
Oman Medical Speciality Board
lead OTHER_GOV
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 3 Years
- Max Age
- 13 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-10-15
- Primary Completion
- 2025-06-01
- Completion
- 2025-06-01
Countries
- Oman
Study Locations
More Related Trials
-
A Comparison of Levalbuterol Plus Ipratropium With Levalbuterol Alone in the Treatment of Acute Asthma Exacerbation
NCT00583778 ·Status: COMPLETED ·Phase: NA
-
Nebulized Ketamine Plus Standard Care vs. Standard Care Alone in Moderate to Severe Asthma Exacerbations
NCT07112456 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
Oral Glucocorticosteroid in the Treatment of Severe Asthma Exacerbation in Hospitalized Patients
NCT00627731 ·Status: COMPLETED ·Phase: PHASE4
-
Study of Drug Exposure in Systemic Circulation of Primatene Mist by Oral Inhalation, Versus Epinephrine Injection by Intramuscular Injection and ProAir by Oral Inhalation in Healthy Individuals
NCT04207840 ·Status: COMPLETED ·Phase: PHASE4
-
Nebulized Procaterol Versus Nebule Salbutamol for the Treatment of Moderate Acute Asthma
NCT00990847 ·Status: COMPLETED ·Phase: PHASE3
-
Safety Study in Adolescent and Adult Patients With Asthma
NCT01476904 ·Status: COMPLETED ·Phase: PHASE3
-
A Chronic-Dose Safety and Efficacy Study of Albuterol Multi-Dose Dry Powder Inhaler in Pediatric Asthmatics
NCT02126839 ·Status: COMPLETED ·Phase: PHASE3
-
Epinephrine Inhalation Aerosol USP, CLINICAL STUDY-B3 FOR ASSESSMENT OF PHARMACOKINETICS
NCT01255709 ·Status: COMPLETED ·Phase: PHASE2
-
Albuterol Versus Xopenex in Treatment of Acute Asthma in the Emergency Department (ED)
NCT00585039 ·Status: COMPLETED ·Phase: PHASE4
-
Nebulized Fluticasone Propionate VS Oral Prednisone in Chinese Pediatric and Adolescent Subjects With an Acute Exacerbation of Asthma
NCT01687296 ·Status: COMPLETED ·Phase: PHASE3
-
A Randomized Trial Comparing Metered Dose Inhalers and Breath Actuated Nebulizers
NCT02777125 ·Status: COMPLETED ·Phase: NA
-
Two Doses of the Intravenous Magnesium Sulfate Versus the Standard Single Dose ,With/ Without the Nebulized Budesonide For the Management of the Severe Asthma Exacerbation in the Emergency Room; A Randomized Controlled Trial.
NCT02455687 ·Status: RECRUITING ·Phase: PHASE3
-
Pharmacokinetic and Pharmacodynamic Profiles of Albuterol Spiromax® and ProAir® Hydrofluoroalkane (HFA) in Pediatric Patients With Asthma
NCT01844401 ·Status: COMPLETED ·Phase: PHASE1
-
Efficacy and Safety of Continuous Versus Intermittent Nebulization of Salbutamol in Acute Severe Asthma in Children Under 12 Years of Age
NCT06754631 ·Status: COMPLETED ·Phase: NA
-
Intramuscular Epinephrine as an Adjunctive Treatment for Severe Pediatric Asthma Exacerbation
NCT01705964 ·Status: COMPLETED ·Phase: PHASE4
-
Use of Dexamethasone in Pediatric Asthma Exacerbations
NCT02192827 ·Status: COMPLETED ·Phase: PHASE3
-
Evaluation of Efficacy and Safety for Single Dose of E004 in Children With Asthma
NCT01737905 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Assess and Compare Safety and Tolerability of 3 Months Treatment With Salbutamol Administered Via MDI Containing Propellant HFA-152a or HFA-134a in Participants ≥ 18 Years of Age With Asthma
NCT06261957 ·Status: COMPLETED ·Phase: PHASE3
-
Pulmicort Respules on Relapse Rates After Treatment in the ED
NCT00584636 ·Status: WITHDRAWN ·Phase: PHASE4
-
Efficacy and Safety of Fluticasone Propionate(FP)/ Salmeterol Xinafoate (SLM) Hydro Fluoro Alkane (HFA) Metered Dose Inhaler (MDI) in Pediatric Patients With Bronchial Asthma
NCT02113436 ·Status: COMPLETED ·Phase: PHASE4
-
Efficacy and Safety Comparison of Albuterol Spiromax® and ProAir® Hydrofluoroalkane (HFA) in Pediatric Patients
NCT01899144 ·Status: COMPLETED ·Phase: PHASE2
-
Inhaled Steroids for Pediatric Asthma at Pediatric Emergency Medicine Discharge
NCT03369847 ·Status: COMPLETED ·Phase: PHASE4
-
Heliox-Powered Albuterol Therapy in the Treatment of Children Admitted With Acute Asthma Exacerbation
NCT00410150 ·Status: TERMINATED ·Phase: PHASE2
-
A 12-Week Study To Assess The Safety Of Fluticasone Propionate/Salmeterol 100/50 Hydrofluoroalkane (HFA) Versus Fluticasone Propionate 100 HFA In Children With Asthma
NCT00441441 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy of Inhaled Albuterol Spiromax® in Subjects With Persistent Asthma With Steady State Pharmacokinetics
NCT01747629 ·Status: COMPLETED ·Phase: PHASE3