Phase 4 Completed N=120 Randomized Triple-blind Prevention

Post Operative Sore Throat and Dexamethasone

Sore throat · Postoperative Pain

Source: ClinicalTrials.gov NCT01052038 ↗

Enrolled (actual)

120

Serious AEs

0.0%

Results posted

May 2012

Primary outcomePrimary: Subjects Assessment of Sore Throat Pain at 24 Hours — 4; 4; 5 units on a scale (1 to 5) — p=<0.001

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.

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

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

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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. Informational only — not medical advice.