Phase 4
N=120
Post Operative Sore Throat and Dexamethasone
Sore Throat · Pain
Bottom Line
View on ClinicalTrials.gov: NCT01052038 ↗Enrolled (actual)
120
Serious AEs
0.0%
Results posted
May 2012
Primary outcome: Primary: Subjects Assessment of Sore Throat Pain at 24 Hours — 4; 4; 5 units on a scale (1 to 5) — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Placebo administration (Drug); Dexamethasone 0.05mg/kr administration (Drug); Dexamethasone 0.1mg/kg (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Northwestern University
- Primary completion
- Sep 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Subjects Assessment of Sore Throat Pain at 24 Hours |
4; 4; 5 | <0.001 sig |
| SECONDARY Quality of Recovery at 24 Hours |
171; 179; 193 | <0.001 sig |
| SECONDARY Number of Subjects With Sore Throat at 3 Hours Post Surgery. |
24; 17; 10 | 0.004 sig |
| SECONDARY Opioid Consumption at 24 Hours |
20; 20; 10 | 0.01 sig |
| SECONDARY Hoarseness at 24 Hours |
5; 11; 18; 10; 6; 8 | 0.04 sig |
Summary
Sore throat is a common postoperative complaint that can lead to morbidity and patient dissatisfaction . The incidence of sore throat has been reported to be between 6% and 90% even under optimal intubating conditions. There are several factors that have been shown to contribute to postoperative sore throat such as patient related factors, type of anesthesia and type of surgery.
Corticosteroids are also commonly used in the perioperative period to potentiate analgesics and as antiemetics. The preoperative administration of dexamethasone can decrease the incidence and severity of postoperative sore throat which is rated by patients as one of the most undesirable outcomes in the postoperative period.
Eligibility Criteria
Inclusion Criteria
- Female patients undergoing outpatient laparoscopic gynecologic surgery
- ASA PS I and II
- Age between 18 and 64 years
- Fluent in English
Exclusion Criteria
- History of recent respiratory tract infection
- Pregnancy, breastfeeding
- Current treatment with analgesics
- Current use of corticosteroids
- Anticipated difficult intubation
- Risk factors for post-operative aspiration
Data sourced from ClinicalTrials.gov (NCT01052038). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.