NCT07495449

Effect of Infusion Warming on Mannitol Infusion Pain in Patients With Acute Ocular Hypertension

Effect of Intravenous Infusion Warming on Pain, Comfort, Phlebitis, and Intraocular Pressure Outcomes During Mannitol Infusion in Patients With Acute Ocular Hypertension: A Randomized Controlled Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 142 (actual)
• Sponsor: Joint Shantou International Eye Center of Shantou University and the Chinese University of Hong Kong · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Acute ocular hypertension requires timely reduction of intraocular pressure to relieve symptoms and reduce the risk of optic nerve damage. Intravenous mannitol is commonly used in ophthalmic emergency care because of its rapid osmotic effect. However, mannitol infusion may cause infusion-related pain, discomfort, slowing or interruption of infusion, and local venous complications such as irritation and phlebitis. These problems may affect both patient experience and treatment efficiency. Warming of intravenous fluids has been used in clinical practice to reduce discomfort associated with infusion of hyperosmotic or irritating solutions. In this study, an infusion warming device was applied during intravenous mannitol administration to examine whether warming could improve the tolerability and clinical performance of mannitol infusion in patients with acute ocular hypertension. Eligible patients requiring intravenous mannitol treatment were assigned to either a warming group or a non-warming group. In the warming group, mannitol was administered through an infusion warming device according to the study protocol. In the non-warming group, mannitol was infused without warming according to routine clinical practice. Patient-reported outcomes and clinical outcomes were assessed during and shortly after infusion. The main objective of the study was to compare infusion-related pain between the two groups. Additional objectives were to compare comfort, infusion efficiency, local infusion-related complications, and short-term intraocular pressure response after treatment. The study was conducted at a tertiary ophthalmic center in China.

Conditions

• Acute Ocular Hypertension Glaucoma
• Intraocular Hypertension
• Primary Angle-Closure Glaucoma

Interventions

Type	Name	Description
DEVICE	Infusion Warming Device	An infusion warming device was used during intravenous mannitol administration to warm the infused fluid according to the study protocol.
OTHER	Routine Non-Warmed Mannitol Infusion	Intravenous mannitol was administered according to routine clinical practice without infusion warming.

Timeline

• Start date: 2025-01-09
• Primary completion: 2025-07-27
• Completion: 2025-07-27
• First posted: 2026-03-27
• Last updated: 2026-03-27

Locations

1 site across 1 country: China