Trial Outcomes & Findings for Effect of NSAID Use on Pain and Opioid Consumption Following Distal Radius Fracture (NCT NCT03749616)

Results Overview

The number and dosing of oxycodone tablets taken per participant for breakthrough pain will be recorded.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

32 participants

Primary outcome timeframe

2 weeks

Results posted on

2024-09-05

Participant Flow

Participant milestones

Participant milestones
Measure	Acetaminophen Acetaminophen will be given to participants for pain control following their injury. Acetaminophen: Control Group - will be administered acetaminophen for pain control with dose and frequency of 325mg 1-2 tablets q4-6h hours as needed, Maximum dose 1000mg. Maximum amount per day: 3g/day.	NSAID Ibuprofen will be given to participants for pain control following their injury. Ibuprofen: NSAID Group - will be administered ibuprofen 400-800 mg, up to three times a day as needed for pain control
Overall Study STARTED	14	18
Overall Study COMPLETED	7	10
Overall Study NOT COMPLETED	7	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Acetaminophen Acetaminophen will be given to participants for pain control following their injury. Acetaminophen: Control Group - will be administered acetaminophen for pain control with dose and frequency of 325mg 1-2 tablets q4-6h hours as needed, Maximum dose 1000mg. Maximum amount per day: 3g/day.	NSAID Ibuprofen will be given to participants for pain control following their injury. Ibuprofen: NSAID Group - will be administered ibuprofen 400-800 mg, up to three times a day as needed for pain control
Overall Study Lost to Follow-up	4	7
Overall Study Screen Failure	1	1
Overall Study Withdrawal by Subject	2	0

Baseline Characteristics

Effect of NSAID Use on Pain and Opioid Consumption Following Distal Radius Fracture

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Acetaminophen n=14 Participants Acetaminophen will be given to participants for pain control following their injury. Acetaminophen: Control Group - will be administered acetaminophen for pain control with dose and frequency of 325mg 1-2 tablets q4-6h hours as needed, Maximum dose 1000mg. Maximum amount per day: 3g/day.	NSAID n=18 Participants Ibuprofen will be given to participants for pain control following their injury. Ibuprofen: NSAID Group - will be administered ibuprofen 400-800 mg, up to three times a day as needed for pain control	Total n=32 Participants Total of all reporting groups
Age, Categorical <=18 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants	14 Participants n=7 Participants	23 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	10 Participants n=7 Participants	21 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	8 Participants n=7 Participants	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	13 Participants n=5 Participants	17 Participants n=7 Participants	30 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 weeks

Population: Data were not collected due to 1.) incomplete medication diaries; and 2.) medication diaries not returned by participants.

The number and dosing of oxycodone tablets taken per participant for breakthrough pain will be recorded.

Outcome measures

Outcome measures
Measure	Acetaminophen n=7 Participants Acetaminophen will be given to participants for pain control following their injury. Acetaminophen: Control Group - will be administered acetaminophen for pain control with dose and frequency of 325mg 1-2 tablets q4-6h hours as needed, Maximum dose 1000mg. Maximum amount per day: 3g/day. Oxycodone 5mg 1-2 tablets q4-6 hours will be available as needed for breakthrough pain.	NSAID n=13 Participants Ibuprofen will be given to participants for pain control following their injury. Ibuprofen: NSAID Group - will be administered ibuprofen 400-800 mg, up to three times a day as needed for pain control. Oxycodone 5mg 1-2 tablets q4-6 hours will be available as needed for breakthrough pain.
Number of Oxycodone Tablets Used for Breakthrough Pain.	16.71 oxycodone tablets Standard Deviation 12.01	9.92 oxycodone tablets Standard Deviation 11.98

PRIMARY outcome

Timeframe: 2 Week, 6 Week, 3 Month, 6 Month and 1 Year Post Surgery

Population: Due to attrition, the number analyzed at each time point is the number of participants who followed up with the research team. A total of 14 participants in the Acetaminophen group, and a total of 18 participants in the NSAID group were analyzed through the various timepoints. Information was captured via a automated Electronic Data Capture program, which resulted in inconsistent follow-up at each timepoint.

The patient will be asked to report their pain on a scale of 0 - 10 using the Visual Analog Scale with 0 being no pain and 10 being the worst pain the patient can imagine.

Outcome measures

Outcome measures
Measure	Acetaminophen n=14 Participants Acetaminophen will be given to participants for pain control following their injury. Acetaminophen: Control Group - will be administered acetaminophen for pain control with dose and frequency of 325mg 1-2 tablets q4-6h hours as needed, Maximum dose 1000mg. Maximum amount per day: 3g/day. Oxycodone 5mg 1-2 tablets q4-6 hours will be available as needed for breakthrough pain.	NSAID n=18 Participants Ibuprofen will be given to participants for pain control following their injury. Ibuprofen: NSAID Group - will be administered ibuprofen 400-800 mg, up to three times a day as needed for pain control. Oxycodone 5mg 1-2 tablets q4-6 hours will be available as needed for breakthrough pain.
Intensity of Pain: Visual Analog Scale (VAS) 2 weeks postop	2.46 score on a scale Standard Deviation 2.07	2.05 score on a scale Standard Deviation 2.82
Intensity of Pain: Visual Analog Scale (VAS) 6 weeks postop	1.0 score on a scale Standard Deviation 1.0	1.25 score on a scale Standard Deviation 1.75
Intensity of Pain: Visual Analog Scale (VAS) 3 months postop	0.75 score on a scale Standard Deviation 1.75	1.88 score on a scale Standard Deviation 2.08
Intensity of Pain: Visual Analog Scale (VAS) 6 months postop	0.88 score on a scale Standard Deviation 1.61	2.55 score on a scale Standard Deviation 3.12
Intensity of Pain: Visual Analog Scale (VAS) 1 year postop	1.11 score on a scale Standard Deviation 1.83	1.66 score on a scale Standard Deviation 2.91

PRIMARY outcome

Timeframe: 6 weeks post surgery

Population: Due to attrition, the number analyzed at each time point is the number of participants who followed up with the research team

Radiographic evidence of boney healing of the distal radius. This outcome measure is reported as the number of participants in each group with fully healed fractures at the designated time point.

Outcome measures

Outcome measures
Measure	Acetaminophen n=9 Participants Acetaminophen will be given to participants for pain control following their injury. Acetaminophen: Control Group - will be administered acetaminophen for pain control with dose and frequency of 325mg 1-2 tablets q4-6h hours as needed, Maximum dose 1000mg. Maximum amount per day: 3g/day. Oxycodone 5mg 1-2 tablets q4-6 hours will be available as needed for breakthrough pain.	NSAID n=9 Participants Ibuprofen will be given to participants for pain control following their injury. Ibuprofen: NSAID Group - will be administered ibuprofen 400-800 mg, up to three times a day as needed for pain control. Oxycodone 5mg 1-2 tablets q4-6 hours will be available as needed for breakthrough pain.
Fractures Fully Healed	9 Participants	9 Participants

SECONDARY outcome

Timeframe: 2 Week, 6 Week, 3 Month, 6 Month and 1 Year Post Surgery

Population: Due to attrition, the number analyzed at each time point is the number of participants who followed up with the research team. At the 1-year postoperative mark, although 9 participants in each group followed up, the questionnaires were not completed. Therefore, the number analyzed is listed as '0' for both groups at this time point

The QuickDASH is a subset of 11 items from the 30-item DASH and is a self-reported questionnaire in which the response options are presented as 5-point Likert scales. At least 10 of the 11 items must be completed for a score to be calculated and the scores range from 0 (no disability) to 100 (most severe disability). This score was designed be useful in patients with any musculoskeletal disorder of the upper limb.

Outcome measures

Outcome measures
Measure	Acetaminophen n=14 Participants Acetaminophen will be given to participants for pain control following their injury. Acetaminophen: Control Group - will be administered acetaminophen for pain control with dose and frequency of 325mg 1-2 tablets q4-6h hours as needed, Maximum dose 1000mg. Maximum amount per day: 3g/day. Oxycodone 5mg 1-2 tablets q4-6 hours will be available as needed for breakthrough pain.	NSAID n=18 Participants Ibuprofen will be given to participants for pain control following their injury. Ibuprofen: NSAID Group - will be administered ibuprofen 400-800 mg, up to three times a day as needed for pain control. Oxycodone 5mg 1-2 tablets q4-6 hours will be available as needed for breakthrough pain.
QuickDASH 6 month postop	43.18 score on a scale Standard Deviation 0	48.86 score on a scale Standard Deviation 4.82
QuickDASH 2 week postop	34.54 score on a scale Standard Deviation 11.74	43.18 score on a scale Standard Deviation 6.76
QuickDASH 6 week postop	42.61 score on a scale Standard Deviation 9.92	47.22 score on a scale Standard Deviation 5.30
QuickDASH 3 month postop	47.16 score on a scale Standard Deviation 2.18	48.10 score on a scale Standard Deviation 4.64

SECONDARY outcome

Timeframe: 2 Weeks, 6 Weeks, 3 Months, 6 Months and 1 Year post surgery

Population: Due to attrition, the number analyzed at each time point is the number of participants who followed up with the research team. At the 1-year postoperative mark, although 9 participants in each group followed up, the questionnaires were not completed by all participants. Therefore, the number of participants who completed the questionnaires and analyzed is listed as at this time point.

The PROMIS UE is scored using a T-score metric, where the mean of the general population is set to 50 with a standard deviation of 10. The minimum score on the PROMIS UE is 0, indicating the lowest level of upper extremity function, while the maximum score is 100, indicating the highest level of upper extremity function. Higher scores represent better upper extremity function.

Outcome measures

Outcome measures
Measure	Acetaminophen n=14 Participants Acetaminophen will be given to participants for pain control following their injury. Acetaminophen: Control Group - will be administered acetaminophen for pain control with dose and frequency of 325mg 1-2 tablets q4-6h hours as needed, Maximum dose 1000mg. Maximum amount per day: 3g/day. Oxycodone 5mg 1-2 tablets q4-6 hours will be available as needed for breakthrough pain.	NSAID n=18 Participants Ibuprofen will be given to participants for pain control following their injury. Ibuprofen: NSAID Group - will be administered ibuprofen 400-800 mg, up to three times a day as needed for pain control. Oxycodone 5mg 1-2 tablets q4-6 hours will be available as needed for breakthrough pain.
Patient Reported Outcomes Measurement Information System (PROMIS) - UE (Upper Extremity) 2 week postop	21.37 score on a scale Standard Deviation 3.2	31.5 score on a scale Standard Deviation 10.44
Patient Reported Outcomes Measurement Information System (PROMIS) - UE (Upper Extremity) 6 week post	34.86 score on a scale Standard Deviation 11.12	40.81 score on a scale Standard Deviation 11.90
Patient Reported Outcomes Measurement Information System (PROMIS) - UE (Upper Extremity) 3 month postop	41.6 score on a scale Standard Deviation 13.57	47.35 score on a scale Standard Deviation 9.18
Patient Reported Outcomes Measurement Information System (PROMIS) - UE (Upper Extremity) 6 month postop	42.3 score on a scale Standard Deviation 0	51.9 score on a scale Standard Deviation 8.91
Patient Reported Outcomes Measurement Information System (PROMIS) - UE (Upper Extremity) 1 year postop	—	58.2 score on a scale Standard Deviation 0

SECONDARY outcome

Timeframe: 2 Week, 6 Week and 3 Month Post Surgery

Population: Due to attrition, the number analyzed at each time point is the number of participants who followed up with the research team. Grip Strength testing was not completed by all participants. Therefore, the number of participants who completed grip strength testing and were analyzed is listed as at these time points.

Grip strength refers to the force exerted by your hand muscles when you hold or squeeze something measured in kilograms. It's an essential measure of hand function and overall health. To assess grip strength, you can use a dynamometer-a device that measures the force applied during a handgrip. The test involves squeezing the dynamometer as hard as possible, typically with the elbow bent at a 90-degree angle. Grip strength varies based on factors such as age, sex and hand dominance.

Outcome measures

Outcome measures
Measure	Acetaminophen n=13 Participants Acetaminophen will be given to participants for pain control following their injury. Acetaminophen: Control Group - will be administered acetaminophen for pain control with dose and frequency of 325mg 1-2 tablets q4-6h hours as needed, Maximum dose 1000mg. Maximum amount per day: 3g/day. Oxycodone 5mg 1-2 tablets q4-6 hours will be available as needed for breakthrough pain.	NSAID n=15 Participants Ibuprofen will be given to participants for pain control following their injury. Ibuprofen: NSAID Group - will be administered ibuprofen 400-800 mg, up to three times a day as needed for pain control. Oxycodone 5mg 1-2 tablets q4-6 hours will be available as needed for breakthrough pain.
Grip Strength 2 week postop	—	10.67 kilograms Standard Deviation 9.54
Grip Strength 6 week postop	12.6 kilograms Standard Deviation 13.26	9.86 kilograms Standard Deviation 8.49
Grip Strength 3 month postop	9.6 kilograms Standard Deviation 5.73	11.0 kilograms Standard Deviation 8.25

SECONDARY outcome

Timeframe: 2 weeks, 6 weeks, and 3 months post surgery

Population: Due to attrition, the number analyzed at each time point is the number of participants who followed up with the research team

Key pinch strength, also known as lateral pinch strength, measures the force exerted by the hand and fingers when pinching an object between the thumb and the radial side of the index finger. Normal ranges typically fall between 10 to 20 pounds of force (4.54 to 9.07 kgs).

Outcome measures

Outcome measures
Measure	Acetaminophen n=14 Participants Acetaminophen will be given to participants for pain control following their injury. Acetaminophen: Control Group - will be administered acetaminophen for pain control with dose and frequency of 325mg 1-2 tablets q4-6h hours as needed, Maximum dose 1000mg. Maximum amount per day: 3g/day. Oxycodone 5mg 1-2 tablets q4-6 hours will be available as needed for breakthrough pain.	NSAID n=18 Participants Ibuprofen will be given to participants for pain control following their injury. Ibuprofen: NSAID Group - will be administered ibuprofen 400-800 mg, up to three times a day as needed for pain control. Oxycodone 5mg 1-2 tablets q4-6 hours will be available as needed for breakthrough pain.
Key Pinch Strength 2 week postop	4.5 kilograms Standard Deviation 3.11	3.25 kilograms Standard Deviation 1.85
Key Pinch Strength 6 week postop	4.74 kilograms Standard Deviation 3.22	5.56 kilograms Standard Deviation 3.41
Key Pinch Strength 3 month postop	4.44 kilograms Standard Deviation 2.18	4.58 kilograms Standard Deviation 1.68

SECONDARY outcome

Timeframe: 2 weeks, 6 weeks and 3 months post surgery

Population: Due to attrition, the number analyzed at each time point is the number of participants who followed up with the research team

Wrist ROM refers to the ability of the wrist to move in different directions. Normal wrist extension ranges from 70°- 90° resulting in a normal flexion-extension arc of 140-180°. The minimum wrist motion required for daily activities is 60° of extension, 54° of flexion, or approximately a 100° flexion-extension arc. ROM can be varied based on factors such as age, sex, and individual anatomy.

Outcome measures

Outcome measures
Measure	Acetaminophen n=14 Participants Acetaminophen will be given to participants for pain control following their injury. Acetaminophen: Control Group - will be administered acetaminophen for pain control with dose and frequency of 325mg 1-2 tablets q4-6h hours as needed, Maximum dose 1000mg. Maximum amount per day: 3g/day. Oxycodone 5mg 1-2 tablets q4-6 hours will be available as needed for breakthrough pain.	NSAID n=18 Participants Ibuprofen will be given to participants for pain control following their injury. Ibuprofen: NSAID Group - will be administered ibuprofen 400-800 mg, up to three times a day as needed for pain control. Oxycodone 5mg 1-2 tablets q4-6 hours will be available as needed for breakthrough pain.
Wrist Range of Motion (ROM) 2 weeks postop	67.5 degrees Standard Deviation 38.89	67.6 degrees Standard Deviation 38.1
Wrist Range of Motion (ROM) 6 weeks postop	89.38 degrees Standard Deviation 57.53	78.89 degrees Standard Deviation 43.12
Wrist Range of Motion (ROM) 3 months postop	76.86 degrees Standard Deviation 43.83	143.75 degrees Standard Deviation 29.26

Adverse Events

Acetaminophen

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

NSAID

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Vicki L Jones

UMissouri

Phone: 573-882-7583

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place