Trial Outcomes & Findings for Dental Pain Study of Analgesics in Patients Undergoing Molar Removal (NCT NCT03652818)

Last Updated: 2021-11-23

Results Overview

Beginning post-surgery (at initiation of Dose 2), Pain Intensity was self-reported over 24 hours, using a pain rating of 0-10 on the Numerical Rating Scale (NRS), with score between 0-10 (0= no pain; 10 = pain as bad as can be). Time weighted sum pain intensity difference scores are reported over 0 to 24 hours. Last observation carried forward method was used.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

115 participants

Primary outcome timeframe

0.5, 0.75, 1, 1.25, 1.75, 2.25 hours (± 5 min) and 3.25, 4.25, 5.25, 6.25, 8.25, 10.25, 12.25, 24 hours (± 10 min)

Results posted on

2021-11-23

Participant Flow

Participants were recruited from June 2018 till September 2018 from the site

Participants were screened from Day-30 to Day 0 before getting randomized

Participant milestones

Participant milestones
Measure	Group A/ Placebo Group Participants received matching placebo capsule orally 60 ± 10 minutes (min) prior to initiating the surgical procedure. Post-surgically the participants received matching placebo capsule orally and matching placebo (saline 100mL) intravenously (IV). The IV infusion was administered over a 15 min period and the capsule was administered immediately prior to the initiation of the IV infusion	Group B/ Acetaminophen (APAP) 1000 mg IV Group Participants received matching placebo capsule orally 60 ± 10 mins prior to initiating the surgical procedure. Post-surgically the participants received matching placebo capsule orally and APAP 1000 milligram (mg) IV. The IV infusion was administered over a 15 min period and the capsule was administered immediately prior to the initiation of the IV infusion.	Group C/ Pregabalin (PGB) 300 mg Capsule Group Participants received matching placebo capsule orally 60 ± 10 mins prior to initiating the surgical procedure. Post-surgically the participants received PGB 300 mg capsule orally and matching placebo (saline 100mL) IV. The IV infusion was administered over a 15 min period and the capsule was administered immediately prior to the initiation of the IV infusion.	Group D/ Combination Co-dosing Group (Post-surgery PGB +APAP) Participants received matching placebo capsule orally 60 ± 10 mins prior to initiating the surgical procedure. Post-surgically the participants received PGB 300 mg capsule orally and APAP 100 mg IV. The IV infusion was administered over a 15 min period and the capsule was administered immediately prior to the initiation of the IV infusion.	Group E/ Combination Split-dosing Group (PGB Pre-surgery + APAP Post-surgery) Participants received PGB 300 mg capsule orally 60 ± 10 mins prior to initiating the surgical procedure. Post-surgically the participants received matching placebo capsule orally and APAP 1000 mg IV. The IV infusion was administered over a 15 min period and the capsule was administered immediately prior to the initiation of the IV infusion
Overall Study STARTED	24	23	22	23	23
Overall Study COMPLETED	22	22	20	22	22
Overall Study NOT COMPLETED	2	1	2	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Group A/ Placebo Group Participants received matching placebo capsule orally 60 ± 10 minutes (min) prior to initiating the surgical procedure. Post-surgically the participants received matching placebo capsule orally and matching placebo (saline 100mL) intravenously (IV). The IV infusion was administered over a 15 min period and the capsule was administered immediately prior to the initiation of the IV infusion	Group B/ Acetaminophen (APAP) 1000 mg IV Group Participants received matching placebo capsule orally 60 ± 10 mins prior to initiating the surgical procedure. Post-surgically the participants received matching placebo capsule orally and APAP 1000 milligram (mg) IV. The IV infusion was administered over a 15 min period and the capsule was administered immediately prior to the initiation of the IV infusion.	Group C/ Pregabalin (PGB) 300 mg Capsule Group Participants received matching placebo capsule orally 60 ± 10 mins prior to initiating the surgical procedure. Post-surgically the participants received PGB 300 mg capsule orally and matching placebo (saline 100mL) IV. The IV infusion was administered over a 15 min period and the capsule was administered immediately prior to the initiation of the IV infusion.	Group D/ Combination Co-dosing Group (Post-surgery PGB +APAP) Participants received matching placebo capsule orally 60 ± 10 mins prior to initiating the surgical procedure. Post-surgically the participants received PGB 300 mg capsule orally and APAP 100 mg IV. The IV infusion was administered over a 15 min period and the capsule was administered immediately prior to the initiation of the IV infusion.	Group E/ Combination Split-dosing Group (PGB Pre-surgery + APAP Post-surgery) Participants received PGB 300 mg capsule orally 60 ± 10 mins prior to initiating the surgical procedure. Post-surgically the participants received matching placebo capsule orally and APAP 1000 mg IV. The IV infusion was administered over a 15 min period and the capsule was administered immediately prior to the initiation of the IV infusion
Overall Study Adverse Event	1	0	0	0	0
Overall Study Physician Decision	1	0	0	0	0
Overall Study Lost to Follow-up	0	1	2	1	1

Baseline Characteristics

One participant from Placebo group (Group A) was withdrawn by physician prior to surgery due to emesis hence Baseline (Day 1) oral examinations was not conducted for this participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group A/ Placebo Group n=24 Participants Pre-surgery placebo and post-surgery placebo 1 and placebo 2	Group B/ APAP Group n=23 Participants Pre-surgery placebo 1 and post-surgery placebo 1 and acetaminophen (APAP)	Group C/ PGB Group n=22 Participants Pre-surgery placebo 1 and post-surgery placebo 2 and pregabalin (PGB)	Group D/ Combination Co-dosing Group n=23 Participants Pre-surgery placebo 1 and post-surgery APAP and PGB	Group E/ Combination Split-dosing Group n=23 Participants Pre-surgery PGB and post-surgery placebo 1 and APAP	Total n=115 Participants Total of all reporting groups
Age, Continuous	17.8 years STANDARD_DEVIATION 1.79 • n=24 Participants	17.8 years STANDARD_DEVIATION 1.48 • n=23 Participants	17.9 years STANDARD_DEVIATION 1.39 • n=22 Participants	17.7 years STANDARD_DEVIATION 0.93 • n=23 Participants	17.6 years STANDARD_DEVIATION 1.31 • n=23 Participants	17.7 years STANDARD_DEVIATION 1.39 • n=115 Participants
Sex: Female, Male Female	12 Participants n=24 Participants	11 Participants n=23 Participants	11 Participants n=22 Participants	12 Participants n=23 Participants	11 Participants n=23 Participants	57 Participants n=115 Participants
Sex: Female, Male Male	12 Participants n=24 Participants	12 Participants n=23 Participants	11 Participants n=22 Participants	11 Participants n=23 Participants	12 Participants n=23 Participants	58 Participants n=115 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=24 Participants	2 Participants n=23 Participants	0 Participants n=22 Participants	4 Participants n=23 Participants	2 Participants n=23 Participants	9 Participants n=115 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	23 Participants n=24 Participants	21 Participants n=23 Participants	22 Participants n=22 Participants	19 Participants n=23 Participants	21 Participants n=23 Participants	106 Participants n=115 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=24 Participants	0 Participants n=23 Participants	0 Participants n=22 Participants	0 Participants n=23 Participants	0 Participants n=23 Participants	0 Participants n=115 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=24 Participants	0 Participants n=23 Participants	0 Participants n=22 Participants	0 Participants n=23 Participants	0 Participants n=23 Participants	0 Participants n=115 Participants
Race (NIH/OMB) Asian	1 Participants n=24 Participants	1 Participants n=23 Participants	0 Participants n=22 Participants	0 Participants n=23 Participants	0 Participants n=23 Participants	2 Participants n=115 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=24 Participants	0 Participants n=23 Participants	0 Participants n=22 Participants	0 Participants n=23 Participants	0 Participants n=23 Participants	0 Participants n=115 Participants
Race (NIH/OMB) Black or African American	0 Participants n=24 Participants	0 Participants n=23 Participants	0 Participants n=22 Participants	0 Participants n=23 Participants	0 Participants n=23 Participants	0 Participants n=115 Participants
Race (NIH/OMB) White	22 Participants n=24 Participants	21 Participants n=23 Participants	22 Participants n=22 Participants	22 Participants n=23 Participants	23 Participants n=23 Participants	110 Participants n=115 Participants
Race (NIH/OMB) More than one race	0 Participants n=24 Participants	1 Participants n=23 Participants	0 Participants n=22 Participants	0 Participants n=23 Participants	0 Participants n=23 Participants	1 Participants n=115 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=24 Participants	0 Participants n=23 Participants	0 Participants n=22 Participants	1 Participants n=23 Participants	0 Participants n=23 Participants	2 Participants n=115 Participants
Body Mass Index	22.86 kg/m^2 STANDARD_DEVIATION 3.716 • n=24 Participants	22.54 kg/m^2 STANDARD_DEVIATION 3.227 • n=23 Participants	22.78 kg/m^2 STANDARD_DEVIATION 3.825 • n=22 Participants	24.02 kg/m^2 STANDARD_DEVIATION 3.788 • n=23 Participants	23.85 kg/m^2 STANDARD_DEVIATION 3.695 • n=23 Participants	23.21 kg/m^2 STANDARD_DEVIATION 3.642 • n=115 Participants
Number of Participants With Mandibular Molar - 17 Moderate to severe partial bony	2 Participants n=23 Participants • One participant from Placebo group (Group A) was withdrawn by physician prior to surgery due to emesis hence Baseline (Day 1) oral examinations was not conducted for this participant.	7 Participants n=23 Participants • One participant from Placebo group (Group A) was withdrawn by physician prior to surgery due to emesis hence Baseline (Day 1) oral examinations was not conducted for this participant.	4 Participants n=22 Participants • One participant from Placebo group (Group A) was withdrawn by physician prior to surgery due to emesis hence Baseline (Day 1) oral examinations was not conducted for this participant.	5 Participants n=23 Participants • One participant from Placebo group (Group A) was withdrawn by physician prior to surgery due to emesis hence Baseline (Day 1) oral examinations was not conducted for this participant.	4 Participants n=23 Participants • One participant from Placebo group (Group A) was withdrawn by physician prior to surgery due to emesis hence Baseline (Day 1) oral examinations was not conducted for this participant.	22 Participants n=114 Participants • One participant from Placebo group (Group A) was withdrawn by physician prior to surgery due to emesis hence Baseline (Day 1) oral examinations was not conducted for this participant.
Number of Participants With Mandibular Molar - 17 Full bony impaction	21 Participants n=23 Participants • One participant from Placebo group (Group A) was withdrawn by physician prior to surgery due to emesis hence Baseline (Day 1) oral examinations was not conducted for this participant.	16 Participants n=23 Participants • One participant from Placebo group (Group A) was withdrawn by physician prior to surgery due to emesis hence Baseline (Day 1) oral examinations was not conducted for this participant.	18 Participants n=22 Participants • One participant from Placebo group (Group A) was withdrawn by physician prior to surgery due to emesis hence Baseline (Day 1) oral examinations was not conducted for this participant.	18 Participants n=23 Participants • One participant from Placebo group (Group A) was withdrawn by physician prior to surgery due to emesis hence Baseline (Day 1) oral examinations was not conducted for this participant.	19 Participants n=23 Participants • One participant from Placebo group (Group A) was withdrawn by physician prior to surgery due to emesis hence Baseline (Day 1) oral examinations was not conducted for this participant.	92 Participants n=114 Participants • One participant from Placebo group (Group A) was withdrawn by physician prior to surgery due to emesis hence Baseline (Day 1) oral examinations was not conducted for this participant.
Number of Participants With Mandibular Molar - 32 Moderate to severe partial bony	4 Participants n=23 Participants • One participant from Placebo group (Group A) was withdrawn by physician prior to surgery due to emesis hence Baseline (Day 1) oral examinations was not conducted for this participant.	7 Participants n=23 Participants • One participant from Placebo group (Group A) was withdrawn by physician prior to surgery due to emesis hence Baseline (Day 1) oral examinations was not conducted for this participant.	5 Participants n=22 Participants • One participant from Placebo group (Group A) was withdrawn by physician prior to surgery due to emesis hence Baseline (Day 1) oral examinations was not conducted for this participant.	4 Participants n=23 Participants • One participant from Placebo group (Group A) was withdrawn by physician prior to surgery due to emesis hence Baseline (Day 1) oral examinations was not conducted for this participant.	3 Participants n=23 Participants • One participant from Placebo group (Group A) was withdrawn by physician prior to surgery due to emesis hence Baseline (Day 1) oral examinations was not conducted for this participant.	23 Participants n=114 Participants • One participant from Placebo group (Group A) was withdrawn by physician prior to surgery due to emesis hence Baseline (Day 1) oral examinations was not conducted for this participant.
Number of Participants With Mandibular Molar - 32 Full bony impaction	19 Participants n=23 Participants • One participant from Placebo group (Group A) was withdrawn by physician prior to surgery due to emesis hence Baseline (Day 1) oral examinations was not conducted for this participant.	16 Participants n=23 Participants • One participant from Placebo group (Group A) was withdrawn by physician prior to surgery due to emesis hence Baseline (Day 1) oral examinations was not conducted for this participant.	17 Participants n=22 Participants • One participant from Placebo group (Group A) was withdrawn by physician prior to surgery due to emesis hence Baseline (Day 1) oral examinations was not conducted for this participant.	19 Participants n=23 Participants • One participant from Placebo group (Group A) was withdrawn by physician prior to surgery due to emesis hence Baseline (Day 1) oral examinations was not conducted for this participant.	19 Participants n=23 Participants • One participant from Placebo group (Group A) was withdrawn by physician prior to surgery due to emesis hence Baseline (Day 1) oral examinations was not conducted for this participant.	90 Participants n=114 Participants • One participant from Placebo group (Group A) was withdrawn by physician prior to surgery due to emesis hence Baseline (Day 1) oral examinations was not conducted for this participant.
Number of Participants With Maxillary Molar -1 Erupted in tissue	2 Participants n=23 Participants • One participant from Placebo group (Group A) was withdrawn by physician prior to surgery due to emesis hence Baseline (Day 1) oral examinations was not conducted for this participant.	1 Participants n=23 Participants • One participant from Placebo group (Group A) was withdrawn by physician prior to surgery due to emesis hence Baseline (Day 1) oral examinations was not conducted for this participant.	1 Participants n=22 Participants • One participant from Placebo group (Group A) was withdrawn by physician prior to surgery due to emesis hence Baseline (Day 1) oral examinations was not conducted for this participant.	0 Participants n=23 Participants • One participant from Placebo group (Group A) was withdrawn by physician prior to surgery due to emesis hence Baseline (Day 1) oral examinations was not conducted for this participant.	0 Participants n=23 Participants • One participant from Placebo group (Group A) was withdrawn by physician prior to surgery due to emesis hence Baseline (Day 1) oral examinations was not conducted for this participant.	4 Participants n=114 Participants • One participant from Placebo group (Group A) was withdrawn by physician prior to surgery due to emesis hence Baseline (Day 1) oral examinations was not conducted for this participant.
Number of Participants With Maxillary Molar -1 Soft tissue impaction	1 Participants n=23 Participants • One participant from Placebo group (Group A) was withdrawn by physician prior to surgery due to emesis hence Baseline (Day 1) oral examinations was not conducted for this participant.	0 Participants n=23 Participants • One participant from Placebo group (Group A) was withdrawn by physician prior to surgery due to emesis hence Baseline (Day 1) oral examinations was not conducted for this participant.	0 Participants n=22 Participants • One participant from Placebo group (Group A) was withdrawn by physician prior to surgery due to emesis hence Baseline (Day 1) oral examinations was not conducted for this participant.	0 Participants n=23 Participants • One participant from Placebo group (Group A) was withdrawn by physician prior to surgery due to emesis hence Baseline (Day 1) oral examinations was not conducted for this participant.	1 Participants n=23 Participants • One participant from Placebo group (Group A) was withdrawn by physician prior to surgery due to emesis hence Baseline (Day 1) oral examinations was not conducted for this participant.	2 Participants n=114 Participants • One participant from Placebo group (Group A) was withdrawn by physician prior to surgery due to emesis hence Baseline (Day 1) oral examinations was not conducted for this participant.
Number of Participants With Maxillary Molar -1 Moderate to severe partial bony	0 Participants n=23 Participants • One participant from Placebo group (Group A) was withdrawn by physician prior to surgery due to emesis hence Baseline (Day 1) oral examinations was not conducted for this participant.	2 Participants n=23 Participants • One participant from Placebo group (Group A) was withdrawn by physician prior to surgery due to emesis hence Baseline (Day 1) oral examinations was not conducted for this participant.	3 Participants n=22 Participants • One participant from Placebo group (Group A) was withdrawn by physician prior to surgery due to emesis hence Baseline (Day 1) oral examinations was not conducted for this participant.	2 Participants n=23 Participants • One participant from Placebo group (Group A) was withdrawn by physician prior to surgery due to emesis hence Baseline (Day 1) oral examinations was not conducted for this participant.	0 Participants n=23 Participants • One participant from Placebo group (Group A) was withdrawn by physician prior to surgery due to emesis hence Baseline (Day 1) oral examinations was not conducted for this participant.	7 Participants n=114 Participants • One participant from Placebo group (Group A) was withdrawn by physician prior to surgery due to emesis hence Baseline (Day 1) oral examinations was not conducted for this participant.
Number of Participants With Maxillary Molar -1 Full bony impaction	20 Participants n=23 Participants • One participant from Placebo group (Group A) was withdrawn by physician prior to surgery due to emesis hence Baseline (Day 1) oral examinations was not conducted for this participant.	17 Participants n=23 Participants • One participant from Placebo group (Group A) was withdrawn by physician prior to surgery due to emesis hence Baseline (Day 1) oral examinations was not conducted for this participant.	17 Participants n=22 Participants • One participant from Placebo group (Group A) was withdrawn by physician prior to surgery due to emesis hence Baseline (Day 1) oral examinations was not conducted for this participant.	21 Participants n=23 Participants • One participant from Placebo group (Group A) was withdrawn by physician prior to surgery due to emesis hence Baseline (Day 1) oral examinations was not conducted for this participant.	22 Participants n=23 Participants • One participant from Placebo group (Group A) was withdrawn by physician prior to surgery due to emesis hence Baseline (Day 1) oral examinations was not conducted for this participant.	97 Participants n=114 Participants • One participant from Placebo group (Group A) was withdrawn by physician prior to surgery due to emesis hence Baseline (Day 1) oral examinations was not conducted for this participant.
Number of Participants With Maxillary Molar -16 Erupted in tissue	0 Participants n=23 Participants • One participant from Placebo group (Group A) was withdrawn by physician prior to surgery due to emesis hence Baseline (Day 1) oral examinations was not conducted for this participant.	0 Participants n=23 Participants • One participant from Placebo group (Group A) was withdrawn by physician prior to surgery due to emesis hence Baseline (Day 1) oral examinations was not conducted for this participant.	0 Participants n=22 Participants • One participant from Placebo group (Group A) was withdrawn by physician prior to surgery due to emesis hence Baseline (Day 1) oral examinations was not conducted for this participant.	1 Participants n=23 Participants • One participant from Placebo group (Group A) was withdrawn by physician prior to surgery due to emesis hence Baseline (Day 1) oral examinations was not conducted for this participant.	0 Participants n=23 Participants • One participant from Placebo group (Group A) was withdrawn by physician prior to surgery due to emesis hence Baseline (Day 1) oral examinations was not conducted for this participant.	1 Participants n=114 Participants • One participant from Placebo group (Group A) was withdrawn by physician prior to surgery due to emesis hence Baseline (Day 1) oral examinations was not conducted for this participant.
Number of Participants With Maxillary Molar -16 Soft tissue impaction	0 Participants n=23 Participants • One participant from Placebo group (Group A) was withdrawn by physician prior to surgery due to emesis hence Baseline (Day 1) oral examinations was not conducted for this participant.	0 Participants n=23 Participants • One participant from Placebo group (Group A) was withdrawn by physician prior to surgery due to emesis hence Baseline (Day 1) oral examinations was not conducted for this participant.	0 Participants n=22 Participants • One participant from Placebo group (Group A) was withdrawn by physician prior to surgery due to emesis hence Baseline (Day 1) oral examinations was not conducted for this participant.	1 Participants n=23 Participants • One participant from Placebo group (Group A) was withdrawn by physician prior to surgery due to emesis hence Baseline (Day 1) oral examinations was not conducted for this participant.	1 Participants n=23 Participants • One participant from Placebo group (Group A) was withdrawn by physician prior to surgery due to emesis hence Baseline (Day 1) oral examinations was not conducted for this participant.	2 Participants n=114 Participants • One participant from Placebo group (Group A) was withdrawn by physician prior to surgery due to emesis hence Baseline (Day 1) oral examinations was not conducted for this participant.
Number of Participants With Maxillary Molar -16 Mild partial bony impaction	0 Participants n=23 Participants • One participant from Placebo group (Group A) was withdrawn by physician prior to surgery due to emesis hence Baseline (Day 1) oral examinations was not conducted for this participant.	0 Participants n=23 Participants • One participant from Placebo group (Group A) was withdrawn by physician prior to surgery due to emesis hence Baseline (Day 1) oral examinations was not conducted for this participant.	1 Participants n=22 Participants • One participant from Placebo group (Group A) was withdrawn by physician prior to surgery due to emesis hence Baseline (Day 1) oral examinations was not conducted for this participant.	0 Participants n=23 Participants • One participant from Placebo group (Group A) was withdrawn by physician prior to surgery due to emesis hence Baseline (Day 1) oral examinations was not conducted for this participant.	0 Participants n=23 Participants • One participant from Placebo group (Group A) was withdrawn by physician prior to surgery due to emesis hence Baseline (Day 1) oral examinations was not conducted for this participant.	1 Participants n=114 Participants • One participant from Placebo group (Group A) was withdrawn by physician prior to surgery due to emesis hence Baseline (Day 1) oral examinations was not conducted for this participant.
Number of Participants With Maxillary Molar -16 Moderate to severe partial bony	1 Participants n=23 Participants • One participant from Placebo group (Group A) was withdrawn by physician prior to surgery due to emesis hence Baseline (Day 1) oral examinations was not conducted for this participant.	2 Participants n=23 Participants • One participant from Placebo group (Group A) was withdrawn by physician prior to surgery due to emesis hence Baseline (Day 1) oral examinations was not conducted for this participant.	4 Participants n=22 Participants • One participant from Placebo group (Group A) was withdrawn by physician prior to surgery due to emesis hence Baseline (Day 1) oral examinations was not conducted for this participant.	1 Participants n=23 Participants • One participant from Placebo group (Group A) was withdrawn by physician prior to surgery due to emesis hence Baseline (Day 1) oral examinations was not conducted for this participant.	1 Participants n=23 Participants • One participant from Placebo group (Group A) was withdrawn by physician prior to surgery due to emesis hence Baseline (Day 1) oral examinations was not conducted for this participant.	9 Participants n=114 Participants • One participant from Placebo group (Group A) was withdrawn by physician prior to surgery due to emesis hence Baseline (Day 1) oral examinations was not conducted for this participant.
Number of Participants With Maxillary Molar -16 Full bony impaction	22 Participants n=23 Participants • One participant from Placebo group (Group A) was withdrawn by physician prior to surgery due to emesis hence Baseline (Day 1) oral examinations was not conducted for this participant.	19 Participants n=23 Participants • One participant from Placebo group (Group A) was withdrawn by physician prior to surgery due to emesis hence Baseline (Day 1) oral examinations was not conducted for this participant.	15 Participants n=22 Participants • One participant from Placebo group (Group A) was withdrawn by physician prior to surgery due to emesis hence Baseline (Day 1) oral examinations was not conducted for this participant.	20 Participants n=23 Participants • One participant from Placebo group (Group A) was withdrawn by physician prior to surgery due to emesis hence Baseline (Day 1) oral examinations was not conducted for this participant.	21 Participants n=23 Participants • One participant from Placebo group (Group A) was withdrawn by physician prior to surgery due to emesis hence Baseline (Day 1) oral examinations was not conducted for this participant.	97 Participants n=114 Participants • One participant from Placebo group (Group A) was withdrawn by physician prior to surgery due to emesis hence Baseline (Day 1) oral examinations was not conducted for this participant.

PRIMARY outcome

Timeframe: 0.5, 0.75, 1, 1.25, 1.75, 2.25 hours (± 5 min) and 3.25, 4.25, 5.25, 6.25, 8.25, 10.25, 12.25, 24 hours (± 10 min)

Population: Efficacy Analysis Population included all randomized participants who received study medication post-surgically and did not experience emesis or other major protocol deviations

Outcome measures

Outcome measures
Measure	Group A/ Placebo Group n=19 Participants Pre-surgery placebo and post-surgery placebo 1 and placebo 2	Group B/ APAP Group n=23 Participants Pre-surgery placebo 1 and post-surgery placebo 1 and acetaminophen (APAP)	Group C/ PGB Group n=21 Participants Pre-surgery placebo 1 and post-surgery placebo 2 and pregabalin (PGB)	Group D/ Combination Co-dosing Group n=22 Participants Pre-surgery placebo 1 and post-surgery APAP and PGB	Group E/ Combination Split-dosing Group n=10 Participants Pre-surgery PGB and post-surgery placebo 1 and APAP
Sum Pain Intensity Difference Scores	-2.4292 score on a scale Standard Error 12.4980	-68.0778 score on a scale Standard Error 11.2879	-68.3533 score on a scale Standard Error 11.8092	-93.3645 score on a scale Standard Error 11.5794	-82.4099 score on a scale Standard Error 17.4418

PRIMARY outcome

Timeframe: 0.5, 0.75, 1, 1.25, 1.75, 2.25 hours (± 5 min) and 3.25, 4.25, 5.25, 6.25, 8.25, 10.25, 12.25, 24 hours (± 10 min)

Population: Efficacy Analysis Population: Included all randomized participants who received study medication post-surgically and did not experience emesis or other major protocol deviations

Beginning post-surgery (at initiation of Dose 2), Pain Relief was self-reported over 24 hours, using a pain rating of 0-10 on the Numerical Rating Scale (NRS), with score between 0-10 (0= no pain; 10 = pain as bad as can be). Time-weighted sum pain total pain relief scores over 24 hours is reported Last observation carried forward method was used.

Outcome measures

Outcome measures
Measure	Group A/ Placebo Group n=19 Participants Pre-surgery placebo and post-surgery placebo 1 and placebo 2	Group B/ APAP Group n=23 Participants Pre-surgery placebo 1 and post-surgery placebo 1 and acetaminophen (APAP)	Group C/ PGB Group n=21 Participants Pre-surgery placebo 1 and post-surgery placebo 2 and pregabalin (PGB)	Group D/ Combination Co-dosing Group n=22 Participants Pre-surgery placebo 1 and post-surgery APAP and PGB	Group E/ Combination Split-dosing Group n=10 Participants Pre-surgery PGB and post-surgery placebo 1 and APAP
Total Pain Relief Measure	17.1038 score on a scale Standard Error 15.5619	88.2775 score on a scale Standard Error 14.0551	94.4433 score on a scale Standard Error 14.7042	121.9596 score on a scale Standard Error 14.4180	91.8373 score on a scale Standard Error 21.7176

SECONDARY outcome

Timeframe: Upto 12.25 hours

Population: Efficacy Analysis Population: Included all randomized participants who received study medication post-surgically and did not experience emesis or other major protocol deviations

Patient global evaluation was self-reported at time of first rescue or at 12.25 hours post-surgery, whichever was first, using a 0-4 categorical rating scale of: (0) poor, (1) fair, (2) good, (3) very good, and (4) excellent. The number of participants with differing patient global evaluation scores were reported.

Outcome measures

Outcome measures
Measure	Group A/ Placebo Group n=19 Participants Pre-surgery placebo and post-surgery placebo 1 and placebo 2	Group B/ APAP Group n=23 Participants Pre-surgery placebo 1 and post-surgery placebo 1 and acetaminophen (APAP)	Group C/ PGB Group n=21 Participants Pre-surgery placebo 1 and post-surgery placebo 2 and pregabalin (PGB)	Group D/ Combination Co-dosing Group n=22 Participants Pre-surgery placebo 1 and post-surgery APAP and PGB	Group E/ Combination Split-dosing Group n=10 Participants Pre-surgery PGB and post-surgery placebo 1 and APAP
Number of Participants With Differing Patient Global Evaluation Scores (0) Poor	13 Participants	1 Participants	8 Participants	0 Participants	0 Participants
Number of Participants With Differing Patient Global Evaluation Scores (4) Excellent	0 Participants	5 Participants	1 Participants	5 Participants	2 Participants
Number of Participants With Differing Patient Global Evaluation Scores (1) Fair	3 Participants	2 Participants	2 Participants	3 Participants	1 Participants
Number of Participants With Differing Patient Global Evaluation Scores (2) Good	1 Participants	7 Participants	4 Participants	4 Participants	1 Participants
Number of Participants With Differing Patient Global Evaluation Scores (3) Very good	2 Participants	8 Participants	6 Participants	10 Participants	6 Participants

SECONDARY outcome

Timeframe: 0.25, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12.0 and 24 hours

Population: Efficacy Analysis Population: Included all randomized participants who received study medication post-surgically and did not experience emesis or other major protocol deviations

Beginning post-surgery (at initiation of Dose 2), participants were given a stopwatch and asked to press the stopwatch if and when they feel first perceptible relief; a record of the time was noted in the participants record. Cumulative number of participants with onset of FPR confirmed after dose 2 and was recorded from 0.25 hour till 24 hours after administration of dose 2.

Outcome measures

Outcome measures
Measure	Group A/ Placebo Group n=19 Participants Pre-surgery placebo and post-surgery placebo 1 and placebo 2	Group B/ APAP Group n=23 Participants Pre-surgery placebo 1 and post-surgery placebo 1 and acetaminophen (APAP)	Group C/ PGB Group n=21 Participants Pre-surgery placebo 1 and post-surgery placebo 2 and pregabalin (PGB)	Group D/ Combination Co-dosing Group n=22 Participants Pre-surgery placebo 1 and post-surgery APAP and PGB	Group E/ Combination Split-dosing Group n=10 Participants Pre-surgery PGB and post-surgery placebo 1 and APAP
Cumulative Number of Participants With Onset of First Perceptible Relief (FPR) Confirmed at 24 Hours After Dose 2	12 Participants	23 Participants	17 Participants	22 Participants	10 Participants

SECONDARY outcome

Timeframe: 0.25, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12.0 and 24 hours

Population: Efficacy Analysis Population: Included all randomized participants who received study medication post-surgically and did not experience emesis or other major protocol deviations

Beginning post-surgery (at initiation of Dose 2), participants were given a stopwatch and asked to press the stopwatch if and when they feel first perceptible relief; a record of the time was noted in the participants record. Cumulative number of participants with onset of MPR confirmed after dose 2 and was recorded from 0.25 hour till 24 hours after administration of dose 2.