Trial Outcomes & Findings for IV vs. Oral Acetaminophen as a Component of Multimodal Analgesia After Total Hip Arthroplasty (NCT NCT03020966)

NCT ID: NCT03020966

Last Updated: 2021-08-10

Results Overview

The Opioid-Related Symptom Distress Scale (ORSDS) is a Likert scale that evaluates 3 symptom distress dimensions (frequency, severity, bothersomeness) for 12 symptoms. Frequency is rated on a 4-point scale (1= 'Rarely', 4= 'Almost constantly'). Severity is rated on a 4-point scale (1= 'Slightly', 4= 'Very'). Bothersomeness is rated on a 5-point scale (0.8= 'Not at all', 4.0= 'Very much'). The symptom-specific ORSDS is the average of the 3 symptom distress dimensions. The composite ORSDS score is the average of 12 symptom-specific scores.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

154 participants

Primary outcome timeframe

24 hours after surgery (Post-operative day 1)

Results posted on

2021-08-10

Participant Flow

Participant milestones

Participant milestones
Measure	Oral Tylenol Patient group receiving 1000mg of oral acetaminophen and an intravenous placebo Acetaminophen: Oral acetaminophen, intravenous placebo	Intravenous Tylenol Patient group receiving 1000mg of intravenous acetaminophen and an oral placebo Acetaminophen: Intravenous acetaminophen, oral placebo
Overall Study STARTED	77	77
Overall Study COMPLETED	75	77
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Oral Tylenol Patient group receiving 1000mg of oral acetaminophen and an intravenous placebo Acetaminophen: Oral acetaminophen, intravenous placebo	Intravenous Tylenol Patient group receiving 1000mg of intravenous acetaminophen and an oral placebo Acetaminophen: Intravenous acetaminophen, oral placebo
Overall Study Withdrawal by Subject	2	0

Baseline Characteristics

IV vs. Oral Acetaminophen as a Component of Multimodal Analgesia After Total Hip Arthroplasty

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Oral Tylenol n=77 Participants Patient group receiving 1000mg of oral acetaminophen and an intravenous placebo Acetaminophen: Oral acetaminophen, intravenous placebo	Intravenous Tylenol n=77 Participants Patient group receiving 1000mg of intravenous acetaminophen and an oral placebo Acetaminophen: Intravenous acetaminophen, oral placebo	Total n=154 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	40 Participants n=5 Participants	39 Participants n=7 Participants	79 Participants n=5 Participants
Age, Categorical >=65 years	37 Participants n=5 Participants	38 Participants n=7 Participants	75 Participants n=5 Participants
Age, Continuous	65 years STANDARD_DEVIATION 10 • n=5 Participants	63 years STANDARD_DEVIATION 10 • n=7 Participants	64 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	42 Participants n=5 Participants	49 Participants n=7 Participants	91 Participants n=5 Participants
Sex: Female, Male Male	35 Participants n=5 Participants	28 Participants n=7 Participants	63 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	74 Participants n=5 Participants	75 Participants n=7 Participants	149 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) White	70 Participants n=5 Participants	69 Participants n=7 Participants	139 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	77 participants n=5 Participants	77 participants n=7 Participants	154 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 hours after the operation (post-operative day 1)

Population: Three patients withdrew from the protocol, but were followed using intention-to-treat principles. One patient did not wish to answer the postoperative questions, 1 could not swallow the pills, and 1 received a different anesthetic/analgesic protocol due to pre-existing expectations.

Numerical rating scale of pain on a scale of 0-10, with 0 representing the minimum value of no pain and 10, representing the maximum, defined as being pain as bad as imaginable.

Outcome measures

Outcome measures
Measure	Oral Tylenol n=75 Participants Patient group receiving 1000mg of oral acetaminophen and an intravenous placebo Acetaminophen: Oral acetaminophen, intravenous placebo	Intravenous Tylenol n=76 Participants Patient group receiving 1000mg of intravenous acetaminophen and an oral placebo Acetaminophen: Intravenous acetaminophen, oral placebo
Pain With Physical Therapy on Post-operative Day 1	3.6 score on a scale Standard Deviation 2.4	3.9 score on a scale Standard Deviation 2.4

PRIMARY outcome

Timeframe: Day of surgery to post-operative day 3

Oral morphine equivalents, cumulative, POD 0-3. Recorded in Medication Usage Database.

Outcome measures

Outcome measures
Measure	Oral Tylenol n=65 Participants Patient group receiving 1000mg of oral acetaminophen and an intravenous placebo Acetaminophen: Oral acetaminophen, intravenous placebo	Intravenous Tylenol n=61 Participants Patient group receiving 1000mg of intravenous acetaminophen and an oral placebo Acetaminophen: Intravenous acetaminophen, oral placebo
Opioid Use	108 Oral Morphine Equivalent (mg) Standard Deviation 63	121 Oral Morphine Equivalent (mg) Standard Deviation 71

PRIMARY outcome

Timeframe: 24 hours after surgery (Post-operative day 1)

Outcome measures

Outcome measures
Measure	Oral Tylenol n=74 Participants Patient group receiving 1000mg of oral acetaminophen and an intravenous placebo Acetaminophen: Oral acetaminophen, intravenous placebo	Intravenous Tylenol n=75 Participants Patient group receiving 1000mg of intravenous acetaminophen and an oral placebo Acetaminophen: Intravenous acetaminophen, oral placebo
Opioid Side Effects	0.4 score on a scale Standard Deviation 0.3	0.3 score on a scale Standard Deviation 0.3

Adverse Events

Oral Tylenol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Intravenous Tylenol

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

Dr. Jacques Yadeau

Hospital for Special Surgery

Phone: (212) 774-2224

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place