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NCT Number: NCT07495449

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

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.

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Key information

Conditions

Acute Ocular Hypertension Glaucoma Eye Diseases Glaucoma Glaucoma, Angle-Closure Intraocular Hypertension Ocular Hypertension Primary Angle-Closure Glaucoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Joint Shantou International Eye Center of Shantou University and The Chinese University of Hong Kong

Shantou, Guangdong, 515041, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Infusion Warming Device

Device

An infusion warming device was used during intravenous mannitol administration to warm the infused fluid according to the study protocol.

Routine Non-Warmed Mannitol Infusion

Other

Intravenous mannitol was administered according to routine clinical practice without infusion warming.

Primary outcomes

  1. Peak pain score during infusion measured by the 11-point Numeric Rating Scale (NRS)

    Time frame: During infusion, up to approximately 45 minutes

    Peak infusion-related pain during intravenous mannitol administration, assessed using the 11-point Numeric Rating Scale (NRS). Scores range from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate worse pain.

Secondary outcomes

  1. Comfort during infusion measured by a 10-point Visual Analogue Scale (VAS)

    Time frame: During infusion, up to approximately 45 minutes

    Patient-reported comfort during intravenous mannitol administration, assessed using a 10-point Visual Analogue Scale (VAS). Scores range from 0 to 10, where 0 indicates the lowest comfort and 10 indicates the highest comfort. Higher scores indicate better comfort.

  2. Maximum infusion rate (drops/minute)

    Time frame: During infusion, up to approximately 45 minutes

    Maximum achievable intravenous infusion rate during mannitol administration, recorded in drops per minute. Higher values indicate faster infusion delivery.

  3. Total infusion duration (minutes)

    Time frame: From infusion start to completion of the full 250 mL infusion, up to approximately 45 minutes

    Total duration of intravenous mannitol infusion, measured in minutes from the start to the completion of the full 250 mL infusion. Lower values indicate shorter infusion duration.

  4. Intraocular pressure measured by iCare rebound tonometry at 30 minutes after infusion

    Time frame: 30 minutes after completion of the full 250 mL infusion

    Intraocular pressure measured using an iCare rebound tonometer. Results are reported in mmHg. Lower values indicate lower intraocular pressure.

  5. Change in intraocular pressure measured by iCare rebound tonometry

    Time frame: From pre-infusion baseline to 30 minutes after completion of the full 250 mL infusion

    Change in intraocular pressure from pre-infusion measurement to the measurement obtained 30 minutes after completion of the full 250 mL infusion, assessed using an iCare rebound tonometer and reported in mmHg. Higher positive values indicate greater reduction in intraocular pressure.

  6. Request for slowing or temporary interruption of infusion due to infusion-related discomfort/pain

    Time frame: During infusion, up to approximately 45 minutes

    Whether the participant requested slowing or temporary interruption of the infusion because of infusion-related discomfort or pain. Reported as yes/no.

  7. Pain affecting mood or rest

    Time frame: During infusion, up to approximately 45 minutes

    Whether infusion-related pain affected participant mood or rest during treatment. Reported as yes/no.

  8. Grade I phlebitis assessed by clinical observation

    Time frame: During infusion and immediately after completion of infusion, up to approximately 1 hour

    Occurrence of infusion-related phlebitis assessed clinically by the nursing team according to local routine practice. Reported as yes/no.

  9. Local redness, swelling, or induration assessed by clinical observation

    Time frame: During infusion and immediately after completion of infusion, up to approximately 1 hour

    Occurrence of local infusion-site redness, swelling, or induration assessed clinically by the nursing team. Reported as yes/no.

Sponsors and collaborators

Lead sponsor

Joint Shantou International Eye Center of Shantou University and the Chinese University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 27, 2026
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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