Conditions: Pain
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 100
Healthy volunteers: no

Brief summary:
The primary purpose of this study was to evaluate analgesic efficacy and safety of hydrocodone/acetaminophen extended release compared to placebo in the treatment of moderate to severe pain following bunionectomy.

Detailed description:
The bunionectomy was performed under regional anesthesia and propofol sedation. Perioperative anesthesia was standardized for all participants. Upon completion of surgery, designated study personnel ensured continued eligibility per the selection criteria of the protocol.

After an appropriate period of time following bunionectomy, participants who had a pain intensity score of ≥ 40 mm on a 100 mm visual analog scale (VAS) and moderate or severe pain intensity per the categorical pain intensity scale were eligible for randomization, in equal numbers, into 1 of 2 treatment arms: hydrocodone/acetaminophen extended release or placebo.

Arms:
arm 1: placebo, 1 oral tablet every 12 hours arm 2: hydrocodone/acetaminophen extended release, 1 oral tablet every 12 hours

Interventions: intervention 1: Hydrocodone/Acetaminophen Extended Release intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: Placebo tablet

Protocol document: