Hydrocodone/Acetaminophen for Acute Pain Following Third Molar Tooth Extraction

TOTPAR (Total Pain Relief)

TOTPAR was the time-interval weighted sum of pain relief. Pain relief was assessed by participants' responses to how their pain relief was compared with the pain they had just before receiving the first dose of study drug: no relief, a little relief, some relief, a lot of relief, or complete relief. Higher mean TOTPAR scores indicate better pain relief. The TOTPAR score is a measure of the cumulative pain intensity difference during treatment and the area under the curve was estimated using the linear trapezoidal rule.

Time frame: From time of first study drug administration to 12 hours following first study drug administration

Time to First Rescue Medication

The median time (minutes) from first dose of study drug to first use of analgesic rescue medication.

Time frame: From time of first study drug administration to 12 hours following first study drug administration

Participants With Adverse Events (AEs)

An adverse event (AE) is defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with treatment. If an adverse event meets any of the following criteria, it is considered a serious adverse event (SAE): results in death or is life-threatening, results in admission or prolongation of hospitalization, results in congenital anomaly or persistent or significant disability/incapacity, or is an important medical event requiring medical or surgical intervention to prevent serious outcome. AEs were categorized by severity (mild, moderate, severe) and relationship to treatment (probably, possibly, probably not, not related). Please see Adverse Events section below for more details.