Post-operative Craniotomy PatientsPhase 4NCT01948505
Effect of IV Acetaminophen on Patients in the Neurocritical Care Unit
A Phase 4 study testing Intravenous acetaminophen in people with Post-operative Craniotomy Patients and Carotid Endarterectomy and Carotid Artery Stenosis Patients, run by University of Utah at 1 site in United States.
Trial summary
To assess the efficacy of an intravenous nonnarcotic pain medication on controlling patient pain. To assess the effect of an intravenous nonnarcotic pain medication on patient sedation levels in neurocritically ill patients. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Post-operative Craniotomy Patients, Carotid Endarterectomy and Carotid Artery Stenosis Patients, Post-op Spine Patients Admitted to the NCCU
- What is being tested?
- Intravenous acetaminophen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Nov 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > 45 kg (amenable to adult dosing)
- all traumatic brain injuries NPO for at least 12 hours
- all post-operative craniotomy patients
- all non-operative subarachnoid hemorrhage, intraparenchymal hemorrhage, and stroke patients
- all carotid endarterectomy and carotid artery stenosis patients
- all endovascular patients undergoing intracranial intervention
- all post-op spine patients admitted to the NCCU
Who cannot join
- documented allergy to acetaminophen
- documented severe hepatic impairment (Child-Pugh score > 6) or severe hepatic disease (hepatitis)
- documented severe renal impairment (CrCl < 30 ml/min) Blood tests will be performed prior to study procedures that will ensure patients do not have renal impairment.
- patients who are pregnant or breast feeding
Trial locations and contacts
1 site in 1 country.
About this study
To assess the efficacy of an intravenous nonnarcotic pain medication on controlling patient pain.
To assess the effect of an intravenous nonnarcotic pain medication on patient sedation levels in neurocritically ill patients.
To assess the effect of an intravenous nonnarcotic pain medication on common side effects seen in patients taking other intravenous narcotic pain medication in the neurocritical care unit.
- Conditions
- Post-operative Craniotomy Patients, Carotid Endarterectomy and Carotid Artery Stenosis Patients, Post-op Spine Patients Admitted to the NCCU, Endovascular Patients Undergoing Intracranial Intervention, Traumatic Brain Injuries NPO for at Least 12 Hours
- Being tested
- Intravenous acetaminophen, Placebo for IV acetaminophen
- Keywords
- Craniotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous acetaminophenDrug
Placebo for IV acetaminophenDrug
Also called Normal Saline
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Active comparator | IV acetaminophen: 1000mg IV q 8 hrs (scheduled) until: a) tolerating PO and IV saline-locked or b) 48 hours reached on medication Receives: Drug: Intravenous acetaminophen |
| Placebo Group | Placebo comparator | IV Normal Saline: 100ml IV q 8 hrs (scheduled) until: a) tolerating PO and IV saline-locked or b) 48 hours reached on medication Receives: Drug: Placebo for IV acetaminophen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Narcotic Requirement After Surgery
The primary efficacy end point was narcotic consumption during the first 48 hours after craniotomy. Opioid usage was calculated by converting the amount of the narcotics taken by the patient into oral morphine equivalents (ME), which were totaled for each postoperative day. At 48 hours after surgery, patients who received IV acetaminophen in addition to our standardized pain protocol did not have a statistically significantly lower mean narcotic requirement, measured in ME, when compared with those in the placebo group.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2013 (estimated)
- Study startAug 2013
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-operative Craniotomy PatientsStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01948505
- Sponsor's protocol ID
- 00061838
- Status last verified
- May 2018
- First submitted
- 18 Sep 2013
- Last updated
- 24 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Sivakumar W, Jensen M, Martinez J, Tanana M, Duncan N, Hoesch R, Riva-Cambrin JK, Kilburg C, Ansari S, House PA. Intravenous acetaminophen for postoperative supratentorial craniotomy pain: a prospective, randomized, double-blinded, placebo-controlled trial. J Neurosurg. 2019 Mar 1;130(3):766-722. doi: 10.3171/2017.10.JNS171464. Epub 2018 Apr 20.
PubMed 29676689
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of IV Acetaminophen on Patients in the Neurocritical Care Unit
- ClinicalTrials.gov ID
- NCT01948505
- Acronym / sponsor ID
- 00061838
- Conditions
- Post-operative Craniotomy Patients, Carotid Endarterectomy and Carotid Artery Stenosis Patients, Post-op Spine Patients Admitted to the NCCU, Endovascular Patients Undergoing Intracranial Intervention, Traumatic Brain Injuries NPO for at Least 12 Hours
- Keywords
- Craniotomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 23 Sep 2013 (estimated)
- Results
- Posted 24 Apr 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the efficacy of an intravenous nonnarcotic pain medication on controlling patient pain.
To assess the effect of an intravenous nonnarcotic pain medication on patient sedation levels in neurocritically ill patients.
To assess the effect of an intravenous nonnarcotic pain medication on common side effects seen in patients taking other intravenous narcotic pain medication in the neurocritical care unit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Active comparator | Drug: Intravenous acetaminophenIV acetaminophen: 1000mg IV q 8 hrs (scheduled) until: a) tolerating PO and IV saline-locked or b) 48 hours reached on medication |
| Placebo Group | Placebo comparator | Drug: Placebo for IV acetaminophenIV Normal Saline: 100ml IV q 8 hrs (scheduled) until: a) tolerating PO and IV saline-locked or b) 48 hours reached on medication |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- > 45 kg (amenable to adult dosing)
- all traumatic brain injuries NPO for at least 12 hours
- all post-operative craniotomy patients
- all non-operative subarachnoid hemorrhage, intraparenchymal hemorrhage, and stroke patients
- all carotid endarterectomy and carotid artery stenosis patients
Key exclusion criteria (4 listed)
- documented allergy to acetaminophen
- documented severe hepatic impairment (Child-Pugh score > 6) or severe hepatic disease (hepatitis)
- documented severe renal impairment (CrCl < 30 ml/min) Blood tests will be performed prior to study procedures that will ensure patients do not have renal impairment.
- patients who are pregnant or breast feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravenous acetaminophen | Drug | Intervention group |
| Placebo for IV acetaminophenAlso: Normal Saline | Drug | Placebo Group |
Primary outcome
Narcotic Requirement After Surgery
Time frame: 48 hours
The primary efficacy end point was narcotic consumption during the first 48 hours after craniotomy. Opioid usage was calculated by converting the amount of the narcotics taken by the patient into oral morphine equivalents (ME), which were totaled for each postoperative day. At 48 hours after surgery, patients who received IV acetaminophen in addition to our standardized pain protocol did not have a statistically significantly lower mean narcotic requirement, measured in ME, when compared with those in the placebo group.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29676689Sivakumar W, Jensen M, Martinez J, Tanana M, Duncan N, Hoesch R, Riva-Cambrin JK, Kilburg C, Ansari S, House PA. Intravenous acetaminophen for postoperative supratentorial craniotomy pain: a prospective, randomized, double-blinded, placebo-controlled trial. J Neurosurg. 2019 Mar 1;130(3):766-722. doi: 10.3171/2017.10.JNS171464. Epub 2018 Apr 20.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intravenous acetaminophen in people with Post-operative Craniotomy Patients and Carotid Endarterectomy and Carotid Artery Stenosis Patients, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Narcotic Requirement After Surgery (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01948505, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2023.