Combined Effect of Dexamethasone and Paracetamol for Postoperative Sore Throat

NCT02252419 | Unknown DMC

• 1 other identifier: SoreThroatParacetamol
• Study Type: interventional
• Target: 242
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators want to evaluate the efficacy of the dexamethasone and paracetamol for the prevention of postoperative sore throat.

Conditions

Pharyngitis

Keywords

Postoperative Period; Anesthesia, General; Intubation, Intratracheal; Dexamethasone; Acetaminophen

Outcome Measures

Primary Outcomes (1)

• Postoperative sore throat

  Postoperative sore throat after 1 hour postoperatively will be measured (0:none, 1:mild, 2:moderate, 3:severe)

  1 hour postoperatively

Secondary Outcomes (11)

• Postoperative sore throat degree

  0, 1, 6, 24 hour postoperatively

• Postoperative pain

  0, 1, 6, 24 hour postoperatively

• Nausea

  0, 1, 6, 24 hour postoperatively

• Vomiting

  0, 1, 6, 24 hour postoperatively

• Somnolence

  0, 1, 6, 24 hour postoperatively

Study Arms (2)

Dexamethasone

ACTIVE COMPARATOR

Dexamethasone will be administered 30 minutes before the anesthetic induction.

Drug: Dexamethasone

Dexamethasone+ Paracetamol (DP)

EXPERIMENTAL

Dexamethasone will be administered 30 minutes before the anesthetic induction. Paracetamol will be administered at the end of the surgery.

Drug: Dexamethasone; Drug: Paracetamol

Interventions

Dexamethasone DRUG

Dexamethasone will be administered.

Dexamethasone; Dexamethasone+ Paracetamol (DP)

Paracetamol DRUG

Paracetamol will be administered.

Dexamethasone+ Paracetamol (DP)

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled for urologic surgery under general anesthesia
• ASA I-III

You may not qualify if:

• Patients with recent sore throat
• Patients with neck surgery
• Patients with anticipated difficult airway
• Patients with Mallampati grade 3
• Patients with severe cardiovascular or pulmonary disease
• Patients with allergic history to dexamethasone or paracetamol
• Patients with liver function disorder
• Patients with liver disease

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seolu National University of Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Pharyngitis

Interventions

Dexamethasone; Acetaminophen

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Hee-Pyoung Park, PhD

  Seoul National University of Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hyun-Chang Kim, MD

CONTACT

82-10-2886-2876; onidori1979@gmail.com

Study Design

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

Study Record Dates

• First Submitted: September 26, 2014
• First Posted: September 30, 2014
• Study Start: October 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: March 1, 2015
• Last Updated: October 17, 2014

Record last verified: 2014-09

Locations

KR (1)