Effect of Infusion Warming on Mannitol Infusion Pain in Patients With Acute Ocular Hypertension (NCT07495449) | Clinical Trial Compass
CompletedNot Applicable
Effect of Infusion Warming on Mannitol Infusion Pain in Patients With Acute Ocular Hypertension
China142 participantsStarted 2025-01-09
Plain-language summary
Acute ocular hypertension is a common ophthalmic emergency that often requires rapid reduction of intraocular pressure. Intravenous mannitol is widely used for this purpose, but infusion-related pain and local venous irritation may reduce patient comfort, interfere with infusion speed, and affect treatment experience. This randomized controlled study aims to evaluate whether use of an infusion warming device during intravenous mannitol administration can reduce infusion-related pain, improve patient comfort, decrease local infusion-related complications, and improve infusion efficiency and short-term intraocular pressure outcomes in patients with acute ocular hypertension.
Participants with acute ocular hypertension who required intravenous mannitol treatment were randomly assigned to either a warming group or a non-warming group. In the warming group, mannitol was administered using an infusion warming device; in the non-warming group, mannitol was administered according to routine practice without warming. Outcomes included peak pain score during infusion, comfort score, infusion rate, infusion duration, local infusion-related adverse reactions, and intraocular pressure change after treatment.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients with acute ocular hypertension requiring intravenous mannitol treatment in the ophthalmology setting
* Age 18 years or older
* Conscious and able to communicate pain and comfort during infusion
* Able to provide informed consent personally or via a legally authorized representative when appropriate
* Able to complete study-related assessments during and shortly after mannitol infusion
Exclusion Criteria:
* Patients who did not require intravenous mannitol treatment
* Known contraindication to intravenous mannitol treatment according to routine clinical practice
* Patients receiving infusion of heat-sensitive fluids or medications for which infusion warming was not appropriate
* Severe cognitive impairment, communication difficulty, or other conditions preventing reliable assessment of pain or comfort
* Failure to complete key study outcome assessments
* Refusal to participate in the study
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial tested whether warming the mannitol IV drip reduces pain during infusion for acute eye pressure crises — if I ever need mannitol treatment, is warmed infusion something your clinic already does or could offer?
2The study measured pain on an 11-point scale during the mannitol drip — how painful is this infusion typically, and does knowing this research existed change how you'd manage my comfort during treatment?
3Since this trial is already completed, has the results influenced current practice for giving mannitol to patients with acute angle-closure glaucoma, and would that affect my treatment plan?
4Mannitol is used to quickly lower dangerously high eye pressure — in my specific situation, is IV mannitol likely to be part of my treatment, or are there other options we should consider first?
5This was a 'Phase NA' or non-drug intervention study focused on a delivery method rather than a new medication — does the fact that it looked at infusion technique rather than a new drug make its findings more immediately applicable to my care?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Peak pain score during infusion measured by the 11-point Numeric Rating Scale (NRS)
Timeframe: During infusion, up to approximately 45 minutes
Trial details
NCT IDNCT07495449
SponsorJoint Shantou International Eye Center of Shantou University and the Chinese University of Hong Kong