A Phase 4 interventional study of Acetaminophen and Placebo in Pain, sponsored by Stanford University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-03-01.
Sponsored by Stanford University · Phase 4, Interventional, and Treatment
The purpose of the study is to determine the efficacy of IV acetaminophen when administered to neurosurgical patients at the beginning and end of their surgery. If the result is improved pain control with less opioid consumption postoperatively, then those patients may also experience less opioid related side effects such as nausea/vomiting, pruritus, and sedation. While numerous other studies have failed to show a benefit of IV acetaminophen after neurosurgical procedures, we are studying the administration of 1 g in two doses over the course of the operation.
10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.
This study's enrollment of 27 is below the median of 66 across 8,493 interventional studies indexed under Pain.
Browse Pain studies →Stanford University is the lead sponsor of 2,168 studies on the registry; 431 are open to participants now.
Of its 267 completed or terminated interventional studies of FDA-regulated products, 207 (78%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients in this group are presenting for 2 surgeries and will be administered intravenous acetaminophen in one surgery and placebo in the other. Patients in this group will be randomized to receive acetaminophen first.
Drug: Acetaminophen · Drug: Placebo
Patients in this group are presenting for 2 surgeries and will be administered intravenous acetaminophen in one surgery and placebo in the other. Patients in this group will be randomized to receive placebo first.
Drug: Acetaminophen · Drug: Placebo
Acetaminophen 1 g intravenous given at the beginning and end of surgery.
Also known as: Tylenol
Placebo to match acetaminophen given at the beginning and end of surgery.
Post-operative Opioid Consumption
From nursing records how much opioid was administered to each patient post-operatively. Opioid use was measured in micrograms (ug) of fentanyl.
Time frame: Up to 24 hours post-operative
Post-operative Pain
Patients were asked to rate their pain on a scale of 1 to 10, with 1 being least pain, and 10 being most pain. Pain was assessed continually once per hour during the post-operative period and the average pain score calculated per participant. The average of the participants' average scores is presented for each group.
Time frame: Up to 24 hours post-operative
Count of Participants Requiring Anti-emetic Administration
Time frame: Up to 24 hours post-operative
| Milestone | Acetaminophen First, Then Placebo | Placebo First, Then Acetaminophen |
|---|---|---|
| Started | 14 | 13 |
| Completed | 12 | 11 |
| Not completed | 2 | 2 |
| Milestone | Acetaminophen First, Then Placebo | Placebo First, Then Acetaminophen |
|---|---|---|
| Started | 12 | 11 |
| Completed | 10 | 10 |
| Not completed | 2 | 1 |
From nursing records how much opioid was administered to each patient post-operatively. Opioid use was measured in micrograms (ug) of fentanyl.
| ug | Acetaminophen | Placebo |
|---|---|---|
| Post-operative Opioid Consumption | 228 ± 125 | 312 ± 165 |
Patients were asked to rate their pain on a scale of 1 to 10, with 1 being least pain, and 10 being most pain. Pain was assessed continually once per hour during the post-operative period and the average pain score calculated per participant. The average of the participants' average scores is presented for each group.
| units on a scale | Acetaminophen | Placebo |
|---|---|---|
| Post-operative hour 0 to 12 | 3.4 ± 2.6 | 3.8 ± 1.8 |
| Post-operative hour 13 to 24 | 2.7 ± 2.5 | 2.6 ± 1.8 |
| Post-operative hour 0 to 24 | 3.1 ± 2.4 | 3.2 ± 1.7 |
| Participants | Acetaminophen | Placebo |
|---|---|---|
| Count of Participants Requiring Anti-emetic Administration | 20 | 20 |
Collected over Up to 2 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Acetaminophen | 2/25 (8%) | 0/25 (0%) | 0/25 (0%) |
| Placebo | 2/25 (8%) | 0/25 (0%) | 0/25 (0%) |
Participants who completed both interventions were included in the analysis.
| Age, Categorical(Participants) | All Study Participants |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 20 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | All Study Participants |
|---|---|
| Female | 16 |
| Male | 4 |
| Race (NIH/OMB)(Participants) | All Study Participants |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 6 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 2 |
| White | 12 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | All Study Participants |
|---|---|
| United States | 20 |
Plan to share: Undecided
Ran from May 2014 to primary completion in Oct 2017, 41 months.
Results were first posted in Mar 2019, 1 year 5 months after primary completion.
Of 280 non-industry phase 4 interventional studies under Pain, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 35. This study's 41 months is above that.
Counting every sponsor, half of 295 studies reached it within 18 months; a quarter within 8 and three quarters within 33.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Acetaminophen