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The Effect of Nebulized Epinephrine in Asthma Exacerbation in Pediatric Age Group With the Standard Treatment Compared to Standard Treatment With Placebo Using Improvement PRAM Score as a Primary Outcome

Sponsor
Oman Medical Speciality Board (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05667727
Collaborator
(none)
30
Enrollment
2
Arms
12
Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: nebulized epinephrine
  • Drug: Normal saline
 Phase 4

Detailed Description

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, the experimental group which include salbutamol (standard dose), ipratropium bromide (standard dose) along with epinephrine (1ml of 1:1000) to given as nebulization.

The other group with given the standard treatment with the same doses with epinephrine. PRAM score with calculated before and at 20, 40, 90 min after the treatment.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
one group will receive (salbutamol and ipratropium) + nebulized epinephrine and the other group will receive (salbutamol and ipratropium) + placebo (normal saline)one group will receive (salbutamol and ipratropium) + nebulized epinephrine and the other group will receive (salbutamol and ipratropium) + placebo (normal saline)
Masking:
Double (Participant, Investigator)
Masking Description:
the clinical pharmacist will label the medications according to coding system, every new patient will be assessed by the treating physician then the staff nurse will provide the intervention (she will known the medication), both participant and the treating physician will be masked.
Primary Purpose:
Treatment
Official Title:
The Effect of Nebulized Epinephrine in Asthma Exacerbation in Pediatric Age Group With the Standard Treatment Compared to Standard Treatment With Placebo
Anticipated Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Jan 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: epinephrine group

this arm will include the participant who will receive the epinephrine plus the standard treatment (salbutamol and ipratropium)

Drug: nebulized epinephrine
we are using 1:1000 epinephrine into nebulization form
Placebo Comparator: control group

in this arm, participant will receive the placebo (normal saline) plus the standard treatment (salbutamol and ipratropium)

Drug: Normal saline
the control group will receive Normal saline (placebo) plus the standard treatment (salbutamol and ipratropium)
Other Names:
  • placebo

    		•

    Outcome Measures

    Primary Outcome Measures

    1. change in pediatric respiratory assessment measure (PRAM) score [at (20) 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 [at (40) 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 [at (90) 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 Outcome Measures

    1. Need for further treatment [through 2 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 [through 2 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 [through 2 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    3 Years to 13 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Age between 3 and 13 years old

    • Pre-existing diagnosis of asthma

    • Presenting to the ED with an asthma exacerbation

    Exclusion Criteria:

    • History of chronic lung or upper airway disease other than asthma

    • History significant, uncorrected congenital heart disease or cardiac arrhythmia

    • Impending respiratory failure

    • Allergy to epinephrine

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Oman Medical Speciality Board

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Adnan Juma Al Rawahi, Emergency Medicine Resident, Oman Medical Speciality Board
    ClinicalTrials.gov Identifier:
    NCT05667727
    Other Study ID Numbers:
    • R2016
    First Posted:
    Dec 29, 2022
    Last Update Posted:
    Dec 29, 2022
    Last Verified:
    Dec 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Asthma
    Dyspnea
    Epinephrine

    Study Results

    No Results Posted as of Dec 29, 2022