Adding a Short Burst of Corticosteroid to the Conventional Treatment of H1 Antihistamines in Emergency Department.
Condition: Urticaria; Allergy
MeSH terms: Urticaria
Study type: Interventional

Summary: 
      A randomized, double-blinded, controlled trial of adding a short burst of corticosteroid to
      the conventional treatment of H1 antihistamines
    

Detailed description: 
      Research Methodology

      Target Population Patients visit emergency room at King chulalongkorn memorial hospital
      (KCMH) age between 18-50 years who meet the following criteria of acute urticarial such as

        1. eruption of wheals, central swelling of various sizes, with or without surrounding
           erythema; with or without angioedema

        2. pruritus or occasional burning sensation

        3. skin returning to normal appearance, usually within 1-24 hours

      Exclusion criteria

        1. patients who have urticarial for more than 48 hours

        2. have severe underlying disease such as heart disease, kidney disease, liver disease

        3. pregnancy

        4. history of Chlorpheniramine, steroid, antihistamines allergy

        5. history of antihistamine or steroid uses within 48 hours before emergency department
           visit

        6. diabetes mellitus

        7. suspected of more severe disease or severe allergic reaction

        8. patients who don't have pruritus

        9. patients who have history of chronic urticaria

      Informed consent process The doctor who is the principal investigator or his assigned
      colleagues describe the research's details and methods to an enrolled patients. The documents
      which contain the details of the research project are also given. Inform consents then were
      signed before the beginning of the experiment.

      The volunteer would be in a research process during their first 1-2 hours in emergency
      department, with the follow up time at 1 week and 1 month

      After the investigator complete the inclusion and exclusion criteria, the participants would
      be random into 3 groups. The randomization process would already be prepared into 3 groups
      with a number coding by the statistician who doesn't get involve in the rest of experiment.
      The drugs would be in the 3 group of sealed envelopes which have 3 kinds of drug combination
      :

        1. Control group : Chlorpheniramine 10 mg/amp ; 1 ampule and cetirizine 10 mg 7 tabs

        2. Experiment group : Chlorpheniramine 10 mg/amp ; 1 ampule, Dexamethasone 5 mg/amp; 1
           ampule and cetirizine 10 mg 7 tabs

        3. Experiment group : Chlorpheniramine 10 mg/amp ; 1 ampule, Dexamethasone 5 mg/amp; 1
           ampule, cetirizine 10 mg 7 tabs, and prednisolone 5 mg 20 tabs After the envelopes are
           sealed, it will be code in an order of number. All of the enrolled patients will get
           Chlorpheniramine 10 mg intravenous. The patients who are assigned in experiment group
           will get an additional Dexamethasone 5 mg intravenous. The preparation of both drugs
           will be result to be a 10 ml of clear fluid. The control group will get a 10 ml of
           sterile fluid in 10 ml syringe as a placebo. The drugs will be prepared and delivered be
           the nurse who knows about the research process but does not get involved in other
           process of the research.

      After the experiment period in emergency department, all of the enrolled patients will get
      cetirizine 10 mg 7 tabs as a home medication. One experiment group will get prednisolone 5 mg
      20 tabs. They will be appointed to an outpatient department in 1 week and 1 month for the
      follow up of an acute urticarial rash.

      Sample size calculation Investigators do the hypothesis that the experiment groups who get
      both Chlorpheniramine 10 mg and Dexamethasone 5 mg intravenous would have the itch score
      decrease at least 2 points so this experiment wants minimal clinical difference at "2". This
      number got from our expert in immunology and skin disease. The standard deviation for this
      experiment is 2.1 from the previous research. Calculated by G*Power version 3.1 (Dusseldorf,
      Germany) for an independent t-test , two-tailed analysis, alpha error probability = 0.05 and
      power of analysis (1-beta error probability) = 0.90 The sample size for each group is 23
      persons so the patients enroll in this research would be 69 persons.

      Data Collection

        1. Sex and age

        2. Time since the first rash erupt before coming to emergency department (hrs)

        3. %body surface area of rash involved

        4. Urticarial activity score (UAS) before and after treatment

        5. Itch score (Visual analog scale (VAS) score) by letting the patients mark a cross on a
           straight line. The end of the left side of a line represents "0 = no pain at all", and
           the end of the right side of a line represents "10 = the worst pain ever possible". The
           patients aren't allowed to compare the previous VAS score before doing the cross.

        6. Side effect of drugs

        7. Other medicine used as indicated

        8. Patients' satisfaction score

        9. The recurrence of rash 1 week after the rash onset

       10. The recurrence of rash 1 month after the rash onset which will be evaluate by an expert
           in immunology and skin disease.

      Data Analysis and Statistics

      Descriptive statistics : Chi-square Student t-test and paired t-test for data analysis of
      continuous variables (such as itch score (VAS) and pair wise comparison for cumulative
      increase in the proportion of the "responder" over the time

      Statistical significant when p-value < 0.05
    

Intervention name(s): IV Dexamethasone; Oral prednisolone
Intervention type(s): Drug; Drug
Intervention description(s): The patients would be random into 3 groups. The randomization process would already be prepared into 3 groups with a number coding by the statistician who doesn't get involve in the rest of experiment. The drugs would be in the 3 group of sealed envelopes which have 3 kinds of drug combination After the envelopes are sealed, it will be code in an order of number. Experiment 1 and Experiment 2 groups would receive IV Dexamethasone in emergency department (ED).; The patients would be random into 3 groups. The randomization process would already be prepared into 3 groups with a number coding by the statistician who doesn't get involve in the rest of experiment. The drugs would be in the 3 group of sealed envelopes which have 3 kinds of drug combination After the envelopes are sealed, it will be code in an order of number. Experiment 2 groups would receive IV Dexamethasone in ED and Oral prednisolone as home medication.
Other intervention name(s): Decadron; Dexasone; Orapred
Intervention MeSH terms: Dexamethasone; Prednisolone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Acute urticaria; Emergency department; Acute allergic syndrome; Corticosteroid; H1-Antihistamines; Chronic urticaria