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Placebo-Controlled Evaluation of Intranasal Dexmedetomidine for Postoperative Analgesia Following Bunionectomy Surgery | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Placebo-Controlled Evaluation of Intranasal Dexmedetomidine for Postoperative Analgesia Following Bunionectomy Surgery

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Evaluation of the Efficacy and Safety of Intranasal Dexmedetomidine for Postoperative Analgesia Following Bunionectomy

NCT02284243•Baudax Bio

View on ClinicalTrials.gov

Summary

The primary objective of this study is to evaluate the analgesic efficacy, on Post-Operative Day (POD) 1, of DEX-IN compared with placebo, using the summed pain intensity difference over the first 48 hours (SPID48) in subjects with acute moderate to severe pain following unilateral bunionectomy.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Voluntarily provide written informed consent.
•Male or female between 18 and 70 years of age, inclusive.
•Be scheduled to undergo a primary unilateral first metatarsal bunionectomy repair
•Be American Society of Anesthesiology (ASA) physical class 1 or 2.
•Female subject are eligible only if all the following apply:
•* Not pregnant;
•* Not lactating;
•* Not planning to become pregnant during the study;
•* Be surgically sterile; or at least two year post menopausal; or have a monogamous partner who is surgically sterile; or is practicing double-barrier contraception; or practicing abstinence; or using an insertable, injectable, transdermal, or combination oral contraceptive.
•Male subjects must be surgically sterile or commit to the use of a reliable method of birth control
+2 more criteria

Exclusion Criteria

•Have a known allergy to dexmedetomidine or any excipient in DEX-IN/placebo or to any peri- or postoperative medications used in this study.
•Have a clinically significant abnormal clinical laboratory test value.
•Have history of or positive test results for HIV, or hepatitis B or C.
•Have a history or clinical manifestations of significant renal, hepatic, cardiovascular, metabolic, neurologic, psychiatric, or other condition that would preclude participation in the study.
•Have a history of migraine or frequent headaches, seizures, or are currently taking anticonvulsants.
•Have another painful physical condition that may confound the assessments of post operative pain.
•Have a history of syncope or other syncopal attacks.
•Have evidence of a clinically significant 12 lead ECG abnormality.
•Have a history of alcohol abuse (regularly drinks \> 4 units of alcohol per day; 8 oz. beer, 3 oz. wine, 1 oz. spirits) or prescription/illicit drug abuse..
•Have positive results on the urine drug screen or alcohol breath test indicative of illicit drug or alcohol abuse.
+11 more criteria

Locations (3)

Trovare Clinical Research, Inc.

Bakersfield, California, United States

Lotus Clinical Research, LLC

Pasadena, California, United States

Endeavor Clinical Trials, P.A.

San Antonio, Texas, United States

Key Dates

Start Date

October 1, 2014

Primary Completion Date

June 1, 2015

Completion Date

June 1, 2015

Last Updated

May 2, 2017

Enrollment

168

ACTUAL participants

Conditions

Pain, Post-operative

Interventions

Intranasal Dexmedetomidine

DRUG

Intranasal Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 2, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Placebo-Controlled Evaluation of Intranasal Dexmedetomidine for Postoperative Analgesia Following Bunionectomy Surgery

Inclusion Criteria

Exclusion Criteria

Controlled Trial to Determine Most Effective Post-Operative Analgesia After Third Molar Extraction

Efficacy, Safety and Tolerability Study of Meloxicam Injection in Subjects After Abdominal Surgery

Evaluation of N1539 Following Abdominoplasty Surgery