Chronic Rhinosinusitis Trial, Completed (NCT01608308)

Chronic Rhinosinusitis Trial, Completed NCT01608308 Sponsor: The University of Texas Health Science Center, Houston Condition: Chronic Rhinosinusitis

Printed from Voxsanity (voxsanity.com.au) — NCT01608308 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.

Back to Chronic Rhinosinusitis

Trial results

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

According to the results reported on ClinicalTrials.gov, this trial involved 62 people who were randomly placed into one of two groups — 31 received intravenous acetaminophen (a painkiller given through a drip) and 31 were in a control group (who did not receive this treatment). All 31 people in the acetaminophen group completed the study, while 29 of the 31 in the control group completed it. The trial was looking at pain levels after surgery, as well as things like the use of additional pain relief medicines and some physical measurements taken in the recovery period. The reported data shows that when pain was measured using a 0–10 scale (where 0 means no pain and 10 means the worst possible pain), both groups scored 0 at one time point. At another time point, the acetaminophen group still scored 0, while the control group scored 2. For additional pain relief after surgery, the acetaminophen group used an average of 1.5 doses of morphine compared to 2.5 doses in the control group. During surgery, 9 people in the acetaminophen group and 4 people in the control group received an extra pain medicine called fentanyl. Regarding nausea after surgery, 13 people in the acetaminophen group and 10 in the control group experienced it. Average blood pressure readings in the recovery period were also recorded — the acetaminophen group had a top-number (systolic) blood pressure of 133 mmHg versus 144 mmHg in the control group, and a bottom-number (diastolic) reading of 75 mmHg versus 78.3 mmHg. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 28542675) ↗

These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

You are having surgery to treat chronic sinus problems (with or without nasal polyps)
Your surgery is expected to last at least 2 hours
At least 3 of your sinuses are affected and will be treated during the surgery

Who may not be able to join:

You have had an allergic reaction or bad reaction to acetaminophen (e.g. Tylenol/paracetamol) in the past
You have severe, end-stage kidney disease
You have severe, end-stage liver disease
You have a history of long-term (chronic) pain, or you have taken opioid (strong painkiller) medication in the last two weeks
You have severe depression or severe anxiety
You are currently taking gabapentin or any other medication used to manage pain (confirm with trial site)
You have a history of sudden (acute) sinus infection or a mucus cyst (mucocele) in the sinuses
You have a history of seizures (epilepsy or otherwise)
You have a known or suspected history of alcohol or drug misuse
You have a known or suspected history of being intolerant to morphine

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.

Last synced 28 July 2026

This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

GP referral letter

Print a one-page summary to share with your doctor.

Voxsanity

Clinical trials and treatments, explained plainly · voxsanity.com.au

Date:

To: My Doctor

Re: Clinical trial enquiry

I found the following past clinical trial relevant to my condition, and wanted to raise it with you. It is no longer recruiting, but I wanted to ask whether similar active trials exist, or whether its results are relevant to my care:

Trial: NCT01608308

Sponsor: The University of Texas Health Science Center, Houston

Phase: Not Applicable

Status: Completed

Condition: Chronic Rhinosinusitis

More information: https://clinicaltrials.gov/study/NCT01608308

Eligibility summary (AI generated)

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

You are having surgery to treat chronic sinus problems (with or without nasal polyps)
Your surgery is expected to last at least 2 hours
At least 3 of your sinuses are affected and will be treated during the surgery

Who may not be able to join:

You have had an allergic reaction or bad reaction to acetaminophen (e.g. Tylenol/paracetamol) in the past
You have severe, end-stage kidney disease
You have severe, end-stage liver disease
You have a history of long-term (chronic) pain, or you have taken opioid (strong painkiller) medication in the last two weeks
You have severe depression or severe anxiety
You are currently taking gabapentin or any other medication used to manage pain (confirm with trial site)
You have a history of sudden (acute) sinus infection or a mucus cyst (mucocele) in the sinuses
You have a history of seizures (epilepsy or otherwise)
You have a known or suspected history of alcohol or drug misuse
You have a known or suspected history of being intolerant to morphine

Important: Always verify eligibility with the trial site directly before applying.

Access in Australia: A treatment being studied in a clinical trial is generally not yet listed on the PBS. Where a medicine is not approved or not available through a trial, the TGA Special Access Scheme may allow a doctor to access unapproved therapeutic goods for individual patients. See voxsanity.com.au/sas-navigator/ for a plain English explainer.

This information was sourced from ClinicalTrials.gov via Voxsanity (data last synced 28 July 2026). It is not medical advice. Please verify the trial's current status directly with the trial site before acting.

Trial details

Status

Completed

Phase

Not Applicable

Sponsor

The University of Texas Health Science Center, Houston

Registry

ClinicalTrials.gov

Start date

1 July 2012

Est. completion

1 September 2014

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Pain Level Assessed Using a Visual Analogue Scale (VAS) Scale

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov