NCT03020966: IV Tylenol

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

Completed Phase 4 Results posted Last updated 10 August 2021

What this trial tests

Phase 4 trial testing Acetaminophen in Pain, Postoperative in 154 participants. Completed in 16 June 2019.

Timeline

16 February 2017

Primary endpoint
16 June 2019

16 June 2019

Quick facts

Lead sponsor	Hospital for Special Surgery, New York
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	154
Start date	16 February 2017
Primary completion	16 June 2019
Estimated completion	16 June 2019
Sites	1 location across United States

Drugs / interventions tested

• Acetaminophen (Paracetamol) — full drug profile →
• Acetaminophen (Paracetamol) — full drug profile →

Conditions studied

• Pain, Postoperative — all drugs for Pain, Postoperative →
• Opioid Use — all drugs for Opioid Use →

Sponsor

Hospital for Special Surgery, New York

Who can join

Adults 18 to 90, any sex, with Pain, Postoperative or Opioid Use. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Pain With Physical Therapy on Post-operative Day 1 Primary · 24 hours after the operation (post-operative day 1)

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.

Group	Value	95% CI
Oral Tylenol	3.6	± 2.4
Intravenous Tylenol	3.9	± 2.4

Opioid Use Primary · Day of surgery to post-operative day 3

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

Group	Value	95% CI
Oral Tylenol	108	± 63
Intravenous Tylenol	121	± 71

Opioid Side Effects Primary · 24 hours after surgery (Post-operative day 1)

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.

Group	Value	95% CI
Oral Tylenol	0.4	± 0.3
Intravenous Tylenol	0.3	± 0.3

Sponsor's own description

The purpose of this study is to determine how well two different methods of administrating Tylenol reduce pain and improve patient satisfaction after total hip replacement (THR) surgery. The methods of administration are orally, via a pill that is to be swallowed, and intravenously. Our aim is to determine whether oral or intravenous administration of Tylenol will reduce opioid consumption and opioid-related side effects after THR.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.