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Analgesic

IV vs Oral Acetaminophen for Postoperative Pain

Phase 4
Recruiting
Research Sponsored by University of Rochester
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be at least 18 years old
Be scheduled for donor nephrectomy or robot-assisted, laparoscopic nephrectomy for cancer at University of Rochester Medical Center
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 20-24 hours post-operatively
Awards & highlights

Study Summary

This trial will compare the effects of two different types of acetaminophen on pain relief for people undergoing different types of nephrectomy surgery.

Who is the study for?
This trial is for adults aged 18-90 scheduled for donor or cancer-related laparoscopic nephrectomy at the University of Rochester Medical Center. Participants must be able to communicate pain using the Numeric Rating Scale and weigh over 50 kg. Those with liver disease, on chronic opioids, unable to take pills, or pregnant are excluded.Check my eligibility
What is being tested?
The study compares the effectiveness of IV acetaminophen versus oral acetaminophen in managing post-operative pain after laparoscopic nephrectomy. Patients will receive either intravenous or enteric acetaminophen without changes to their standard surgical and post-op care.See study design
What are the potential side effects?
Potential side effects include reactions at the injection site for IV acetaminophen, gastrointestinal issues like nausea or constipation from both forms, and rare cases of liver damage if taken in high doses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.
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I am scheduled for a kidney removal surgery at University of Rochester Medical Center.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~20-24 hours post-operatively
This trial's timeline: 3 weeks for screening, Varies for treatment, and 20-24 hours post-operatively for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Compare pain control for oral and intravenous acetaminophen for post-operative pain control. This will include opiates administered intra-operatively.
Secondary outcome measures
Average surgical pain intensity
Average surgical pain intensity on a 0-10 numeric rating scale (NRS)
Mean Inspiratory capacity
+6 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: IV acetaminophen and placebo pillsActive Control2 Interventions
Group II: placebo IV (normal saline) + oral acetaminophenPlacebo Group2 Interventions

Find a Location

Who is running the clinical trial?

University of RochesterLead Sponsor
836 Previous Clinical Trials
517,903 Total Patients Enrolled
1 Trials studying Nephrectomy
70 Patients Enrolled for Nephrectomy

Media Library

acetaminophen (Analgesic) Clinical Trial Eligibility Overview. Trial Name: NCT03365622 — Phase 4
Nephrectomy Research Study Groups: placebo IV (normal saline) + oral acetaminophen, IV acetaminophen and placebo pills
Nephrectomy Clinical Trial 2023: acetaminophen Highlights & Side Effects. Trial Name: NCT03365622 — Phase 4
acetaminophen (Analgesic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03365622 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Am I eligible to be a participant in this research endeavor?

"In order to qualify for this trial, patients must have undergone nephrectomy and be between 18-89 years old. There are a total of 235 spots available."

Answered by AI

How many maximum participants are accepted in this medical research?

"Affirmative. According to information available on clinicaltrials.gov, this research project is presently recruiting participants after being initially published on August 8th 2018 and last updated November 7th 2022. The study aims to recruit 235 patients from a single location."

Answered by AI

What ailments is this treatment typically employed to address?

"This therapy is effective in managing catarrh, rhinorrhoea, and musculoskeletal pain."

Answered by AI

How reliable is this method of treatment for patients in terms of risk?

"There is a wealth of evidence regarding the safety and efficacy of this treatment, which has earned it an impressive score of 3."

Answered by AI

Are minors being considered for participation in this research?

"The parameters of this medical trial require applicants to be between 18 and 89 years old. Meanwhile, there are 31 trials designed for patients below the age of majority as well as 63 studies prioritizing those who have surpassed traditional retirement age."

Answered by AI

What prior experiments have been conducted regarding this treatment?

"Currently, 89 research trials are underway concerning this treatment. Of those active studies, 26 are in Phase 3 of the clinical trial process. Although most of these investigations take place in Pittsburgh, Pennsylvania, 1003 different sites administer the study's protocol worldwide."

Answered by AI

Are there any openings left for those who wish to participate in this experiment?

"Affirmative. According to clinicaltrials.gov, this research trial is actively seeking participants and was first published on August 8th 2018 with a most recent update occurring November 7th 2022. The study needs 235 volunteers from one site in particular."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Efficacy of IV Acetaminophen Versus Oral Acetaminophen
Joseph W Dooley, MD 2018. "Efficacy of IV Acetaminophen Versus Oral Acetaminophen". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03365622.
~11 spots leftby Jul 2024
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