Adding a Short Burst of Corticosteroid to the Conventional Treatment of H1 Antihistamines in Emergency Department.

NCT03296358 | Completed DMC

• 1 other identifier: 668/2017
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Urticaria; Allergy

Keywords

Acute urticaria; Emergency department; Acute allergic syndrome; Corticosteroid; H1-Antihistamines; Chronic urticaria

Outcome Measures

Primary Outcomes (1)

• Itch score

  letting the patients mark a cross on a straight line. The end of the left side of a line represents "0 = no itch at all", and the end of the right side of a line represents "10 = the worst itch ever possible". The patients aren't allowed to compare the previous VAS score before doing the cross.

  60 mins

Secondary Outcomes (2)

• Chronic urticaria incidence

  1 week, 1 month

• Itch score

  0, 15, 30 mins

Study Arms (3)

Control group

NO INTERVENTION

Chlorpheniramine 10 mg/amp ; 1 ampule Cetirizine 10 mg 7 tabs once daily (OD) as home medication

Experiment 1

EXPERIMENTAL

Chlorpheniramine 10 mg/amp ; 1 ampule, IV Dexamethasone 5 mg/amp; 1 ampule Cetirizine 10 mg 7 tabs 1 tab OD as home medication

Drug: IV Dexamethasone

Experiment 2

EXPERIMENTAL

Chlorpheniramine 10 mg/amp ; 1 ampule, IV Dexamethasone 5 mg/amp; 1 ampule Cetirizine 10 mg 7 tabs 1 tab OD as home medication Oral prednisolone 5 mg 20 tabs ; 2\*2 po pc as home medication

Drug: IV Dexamethasone; Drug: Oral prednisolone

Interventions

IV Dexamethasone DRUG

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).

Also known as: Decadron, Dexasone

Experiment 1; Experiment 2

Oral prednisolone DRUG

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.

Also known as: Orapred

Experiment 2

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• eruption of wheals, central swelling of various sizes, with or without surrounding erythema; with or without angioedema
• pruritus or occasional burning sensation
• skin returning to normal appearance, usually within 1-24 hours

You may not qualify if:

• patients who have urticarial for more than 48 hours
• have severe underlying disease such as heart disease, kidney disease, liver disease
• pregnancy
• history of chlorpheniramine maleate, steroid, antihistamines allergy
• history of antihistamine or steroid uses within 48 hours before ED visit
• diabetes mellitus
• suspected of more severe disease or severe allergic reaction
• patients who don't have pruritus
• patients who have history of chronic urticaria

Sponsors & Collaborators

• Chulalongkorn University: lead

Study Sites (1)

Chulalongkorn Hospital

Pathum Wan, Bangkok, 10600, Thailand

Location

MeSH Terms

Conditions

Urticaria; Hypersensitivity; Emergencies; Chronic Urticaria

Interventions

Dexamethasone; Calcium Dobesilate; Prednisolone; Methylprednisolone

Condition Hierarchy (Ancestors)

Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Chronic Disease

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Pakhawadee Palungwachira, M.D.

  King Chulalongkorn Memorial Hospital and Faculty of Medicine, Chulalongkorn University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2017
• First Posted: September 28, 2017
• Study Start: October 1, 2017
• Primary Completion: October 31, 2019
• Study Completion: October 31, 2019
• Last Updated: February 11, 2020

Record last verified: 2020-01

Locations

TH (1)