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NCT Number: NCT05667727

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

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.

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Key information

Conditions

Shortness of Breath Asthma in Children Dyspnea Epinephrine Causing Adverse Effects in Therapeutic Use Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Salbutamol Adverse Reaction Signs and Symptoms Signs and Symptoms, Respiratory

Age range

3 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Royal Hospital

Muscat, Oman

About this study

Because there are no previous studies with the same methodology found, pilot study will be conducted to estimate the sample size.

Patients who are eligible to be enrolled in the study will be randomized into two group (after receiving the standard of care, 3 back to back nebulization (salbutamol and ipratropium bromide)) , the experimental group will be given epinephrine (1ml of 1:1000) as nebulization and the control group will receive salbutamol nebulization as 4th nebulization.

PRAM score with calculated before and at 60, 80, 100 min after the treatment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • Inclusion Criteria:
  • Pediatric age group 3 - 12 years
  • known to have asthma
  • Initial PRAM Score showed moderate to severe asthma exacerbation
  • Exclusion Criteria:
  • History of lung or upper airway disease other than asthma:
  • bronchiolitis, anaphylaxis, pertussis, vocal cord dysfunction, foreign body aspiration, bronchopulmonary dysplasia, cystic fibrosis and lower airway mass effects
  • History of congenital heart disease or cardiac arrhythmia or heart failure.
  • Known hypertension
  • Impending respiratory failure (Decreasing mental status, Respiratory fatigue, Impending respiratory arrest, Hypoxemia (pO2 < 60 mmHg), pCO2 could be normal or high)
  • Allergy or hypersensitivity to epinephrine
  • Patient/Parents refusal to participate in the study

Treatment and study plan

Nebulized Epinephrine

Drug

we are using 1:1000 epinephrine into nebulization form

Salbutamol

Drug

Patient will receive salbutamol as 4th nebulization.

Other names: The control

Primary outcomes

  1. change in pediatric respiratory assessment measure (PRAM) score

    Time frame: at (60) mints

    treating physician will calculate the PRAM score before and immediately after the intervention by 20 mins, if there is no change in PRAM score or the case worsen, candidate will receive further treatment, but if he/she improved, will be assessed in the second interval.

  2. change in pediatric respiratory assessment measure (PRAM) score

    Time frame: at (80) mints

    immediately after the intervention by 40 mins, candidate will be assessed, calculating the PRAM score again, and decide he/she will need further treatment or to continue observation.

  3. change in pediatric respiratory assessment measure (PRAM) score

    Time frame: at (100) mints

    immediately after the intervention by 90 mins, candidate will be assessed again, calculating the PRAM score and decide about if he will need further treatment or no.

    Total observation will be almost 2 hours in order to look for other outcome as well.

Secondary outcomes

  1. Emergency Department (ED) length of stay

    Time frame: from the randomization up to 4 hours

    "during the assessment", after the exposure

    This outcome will be decided upon each reassessment intervals, at any time during assessment if there is no change in PRAM score or worsening patient will receive further treatment as decided before and his enrollment in the study will be ended here.

  2. The rate for admission

    Time frame: from the randomization up to 4 hours

    "during the assessment"

    this will be determined at the disposal plan for each candidate from the emergency department, either admission or discharge home.

  3. rate of any side effect of nebulized epinephrine

    Time frame: from the randomization up to 4 hours

    "during the assessment"

    Each candidate will be assessed throughout the enrolment in the study, starting from the administration of the medication till 2 hours post exposure.

  4. The need for respiratory support (O2, Non-invasive ventilation, intubation)

    Time frame: from the randomization to the disposal time

    "during assessment"

  5. The rate of revisit to Emergency Department within 72 hours of the index visit

    Time frame: Till 72 hours post discharge

    "after discharge"

Sponsors and collaborators

Lead sponsor

Oman Medical Speciality Board

Other Gov

Registry information

Official study title

The Effect of Adding Nebulized Epinephrine in Asthma Exacerbation Management in Pediatric Age Group Compared to Standard of Care: Superiority Trial

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Dec 29, 2022
Registry last updated
Jun 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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