Trial Outcomes & Findings for Pre-emptive Analgesics in Orthodontic Treatment (NCT NCT03523988)

Results Overview

Pain scores were measured and recorded by selecting a number \[0-10\] using a visual analog scale to assess pain during the following actions: jaw at rest, lightly biting, and chewing paraffin wax. The VAS consisted of a 10cm numerical scale from 0, representing "no pain," to 10, representing "worst possible, unbearable, excruciating pain."

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

73 participants

Primary outcome timeframe

6 hours after orthodontic treatment

Results posted on

2019-08-21

Participant Flow

Orthodontic patients that presented to the University of Washington Graduate Orthodontics Clinic between May 2nd and June 23rd, 2017 were approached for recruitment.

Participants were screened against a set of inclusion criteria during the informed consent process. If one or more of the inclusion were not met then the patient was not assigned to a group.

Participant milestones

Participant milestones
Measure	Acetaminophen Acetaminophen 650mg powder in gel capsule taken by mouth before entering appointment Acetaminophen: Acetaminophen gel capsule	Ibuprofen Ibuprofen 400mg powder in gel capsule taken by mouth before entering appointment Ibuprofen: Ibuprofen gel capsule	Acetaminophen and Ibuprofen Acetaminophen 650mg and Ibuprofen 400mg powder in gel capsule taken by mouth before entering appointment Acetaminophen: Acetaminophen gel capsule Ibuprofen: Ibuprofen gel capsule
Overall Study STARTED	24	24	25
Overall Study COMPLETED	7	8	7
Overall Study NOT COMPLETED	17	16	18

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Acetaminophen and Ibuprofen n=7 Participants Acetaminophen 650mg and Ibuprofen 400mg powder in gel capsule taken by mouth before entering appointment Acetaminophen: Acetaminophen gel capsule Ibuprofen: Ibuprofen gel capsule	Total n=22 Participants Total of all reporting groups	Acetaminophen n=7 Participants Acetaminophen 650mg powder in gel capsule taken by mouth before entering appointment Acetaminophen: Acetaminophen gel capsule	Ibuprofen n=8 Participants Ibuprofen 400mg powder in gel capsule taken by mouth before entering appointment Ibuprofen: Ibuprofen gel capsule
Age, Continuous	21.4 years STANDARD_DEVIATION 15.3 • n=7 Participants	23.1 years STANDARD_DEVIATION 14.3 • n=22 Participants	21.7 years STANDARD_DEVIATION 9.6 • n=7 Participants	25.9 years STANDARD_DEVIATION 18.0 • n=8 Participants
Sex: Female, Male Female	3 Participants n=7 Participants	12 Participants n=22 Participants	6 Participants n=7 Participants	3 Participants n=8 Participants
Sex: Female, Male Male	4 Participants n=7 Participants	10 Participants n=22 Participants	1 Participants n=7 Participants	5 Participants n=8 Participants
Race and Ethnicity Not Collected	—	0 Participants Race and Ethnicity were not collected from any participant.	—	—
Region of Enrollment United States	7 participants n=7 Participants	22 participants n=22 Participants	7 participants n=7 Participants	8 participants n=8 Participants

PRIMARY outcome

Timeframe: 6 hours after orthodontic treatment

Pain scores were measured and recorded by selecting a number \[0-10\] using a visual analog scale to assess pain during the following actions: jaw at rest, lightly biting, and chewing paraffin wax. The VAS consisted of a 10cm numerical scale from 0, representing "no pain," to 10, representing "worst possible, unbearable, excruciating pain."

Outcome measures

Outcome measures
Measure	Acetaminophen n=7 Participants Acetaminophen 650mg powder in gel capsule taken by mouth before entering appointment Acetaminophen: Acetaminophen gel capsule	Ibuprofen n=8 Participants Ibuprofen 400mg powder in gel capsule taken by mouth before entering appointment Ibuprofen: Ibuprofen gel capsule	Acetaminophen and Ibuprofen n=7 Participants Acetaminophen 650mg and Ibuprofen 400mg powder in gel capsule taken by mouth before entering appointment Acetaminophen: Acetaminophen gel capsule Ibuprofen: Ibuprofen gel capsule
Visual Analog Scale (VAS) Pain Scores at 6 Hours After Treatment Rest	0.6 scores on a scale Standard Deviation 0.8	2.6 scores on a scale Standard Deviation 2.2	1.0 scores on a scale Standard Deviation 1.0
Visual Analog Scale (VAS) Pain Scores at 6 Hours After Treatment Biting	2.0 scores on a scale Standard Deviation 1.4	2.9 scores on a scale Standard Deviation 2.5	2.0 scores on a scale Standard Deviation 1.9
Visual Analog Scale (VAS) Pain Scores at 6 Hours After Treatment Chewing	2.3 scores on a scale Standard Deviation 1.4	4.0 scores on a scale Standard Deviation 3.1	3.1 scores on a scale Standard Deviation 2.5

PRIMARY outcome

Timeframe: 1 day after orthodontic treatment

Pain scores were measured and recorded by selecting a number \[0-10\] using a visual analog scale to assess pain during the following actions: jaw at rest, lightly biting, and chewing paraffin wax. The VAS consisted of a 10cm numerical scale from 0, representing "no pain," to 10, representing "worst possible, unbearable, excruciating pain."

Outcome measures

Outcome measures
Measure	Acetaminophen n=7 Participants Acetaminophen 650mg powder in gel capsule taken by mouth before entering appointment Acetaminophen: Acetaminophen gel capsule	Ibuprofen n=8 Participants Ibuprofen 400mg powder in gel capsule taken by mouth before entering appointment Ibuprofen: Ibuprofen gel capsule	Acetaminophen and Ibuprofen n=7 Participants Acetaminophen 650mg and Ibuprofen 400mg powder in gel capsule taken by mouth before entering appointment Acetaminophen: Acetaminophen gel capsule Ibuprofen: Ibuprofen gel capsule
Visual Analog Scale (VAS) Pain Scores at 1 Day After Treatment Biting	2.9 scores on a scale Standard Deviation 2.5	2.5 scores on a scale Standard Deviation 2.1	2.1 scores on a scale Standard Deviation 2.7
Visual Analog Scale (VAS) Pain Scores at 1 Day After Treatment Chewing	3.6 scores on a scale Standard Deviation 2.8	3.9 scores on a scale Standard Deviation 3.1	2.7 scores on a scale Standard Deviation 1.7
Visual Analog Scale (VAS) Pain Scores at 1 Day After Treatment Rest	1.9 scores on a scale Standard Deviation 2.5	2.0 scores on a scale Standard Deviation 1.7	1.1 scores on a scale Standard Deviation 1.2

PRIMARY outcome

Timeframe: 2 days after orthodontic treatment

Pain scores were measured and recorded by selecting a number \[0-10\] using a visual analog scale to assess pain during the following actions: jaw at rest, lightly biting, and chewing paraffin wax. The VAS consisted of a 10cm numerical scale from 0, representing "no pain," to 10, representing "worst possible, unbearable, excruciating pain."

Outcome measures

Outcome measures
Measure	Acetaminophen n=7 Participants Acetaminophen 650mg powder in gel capsule taken by mouth before entering appointment Acetaminophen: Acetaminophen gel capsule	Ibuprofen n=8 Participants Ibuprofen 400mg powder in gel capsule taken by mouth before entering appointment Ibuprofen: Ibuprofen gel capsule	Acetaminophen and Ibuprofen n=7 Participants Acetaminophen 650mg and Ibuprofen 400mg powder in gel capsule taken by mouth before entering appointment Acetaminophen: Acetaminophen gel capsule Ibuprofen: Ibuprofen gel capsule
Visual Analog Scale (VAS) Pain Scores at 2 Days After Treatment Chewing	2.9 scores on a scale Standard Deviation 2.9	3.1 scores on a scale Standard Deviation 2.0	1.6 scores on a scale Standard Deviation 1.4
Visual Analog Scale (VAS) Pain Scores at 2 Days After Treatment Rest	1.3 scores on a scale Standard Deviation 2.6	1.4 scores on a scale Standard Deviation 1.5	0.4 scores on a scale Standard Deviation 0.5
Visual Analog Scale (VAS) Pain Scores at 2 Days After Treatment Biting	2.3 scores on a scale Standard Deviation 2.9	2.3 scores on a scale Standard Deviation 1.5	0.9 scores on a scale Standard Deviation 1.1

Adverse Events

Acetaminophen

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Ibuprofen

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Acetaminophen and Ibuprofen

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Acetaminophen n=24 participants at risk Acetaminophen 650mg powder in gel capsule taken by mouth before entering appointment Acetaminophen: Acetaminophen gel capsule	Ibuprofen n=24 participants at risk Ibuprofen 400mg powder in gel capsule taken by mouth before entering appointment Ibuprofen: Ibuprofen gel capsule	Acetaminophen and Ibuprofen n=25 participants at risk Acetaminophen 650mg and Ibuprofen 400mg powder in gel capsule taken by mouth before entering appointment Acetaminophen: Acetaminophen gel capsule Ibuprofen: Ibuprofen gel capsule
General disorders Acute Headache	0.00% 0/24 • Participants were given the contact information (phone and email) of the Lead Researcher to self-report any adverse events that occurred from the time they were administered their drug to the time of the last data entry (2 days following administration).	0.00% 0/24 • Participants were given the contact information (phone and email) of the Lead Researcher to self-report any adverse events that occurred from the time they were administered their drug to the time of the last data entry (2 days following administration).	4.0% 1/25 • Number of events 1 • Participants were given the contact information (phone and email) of the Lead Researcher to self-report any adverse events that occurred from the time they were administered their drug to the time of the last data entry (2 days following administration).

Additional Information

Lead Investigator

University of Washington

Phone: 4254668544

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place