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

NCT07495449 | Completed

• 1 other identifier: EC 20240924(7)-P07
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Mannitol Infusion Warming; Intravenous Infusion; Infusion Pain; Intraocular Pressure; Ocular Hypertension; Ophthalmic Nursing

Outcome Measures

Primary Outcomes (1)

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

  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.

  During infusion, up to approximately 45 minutes

Secondary Outcomes (9)

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

  During infusion, up to approximately 45 minutes

• Maximum infusion rate (drops/minute)

  During infusion, up to approximately 45 minutes

• Total infusion duration (minutes)

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

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

  30 minutes after completion of the full 250 mL infusion

• Change in intraocular pressure measured by iCare rebound tonometry

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

Study Arms (2)

Warming Group

EXPERIMENTAL

Participants received intravenous mannitol infusion using an infusion warming device during treatment for acute ocular hypertension.

Device: Infusion Warming Device

Non-Warming Group

ACTIVE COMPARATOR

Participants received routine intravenous mannitol infusion without use of an infusion warming device during treatment for acute ocular hypertension.

Other: Routine Non-Warmed Mannitol Infusion

Interventions

Infusion Warming Device DEVICE

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

Warming Group

Routine Non-Warmed Mannitol Infusion OTHER

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

Non-Warming Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

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

Shantou, Guangdong, 515041, China

Location

Related Publications (6)

• Lam DS, Chua JK, Tham CC, Lai JS. Efficacy and safety of immediate anterior chamber paracentesis in the treatment of acute primary angle-closure glaucoma: a pilot study. Ophthalmology. 2002 Jan;109(1):64-70. doi: 10.1016/s0161-6420(01)00857-0.

  PMID: 11772581 RESULT

• Lam DS, Lai JS, Tham CC, Chua JK, Poon AS. Argon laser peripheral iridoplasty versus conventional systemic medical therapy in treatment of acute primary angle-closure glaucoma : a prospective, randomized, controlled trial. Ophthalmology. 2002 Sep;109(9):1591-6. doi: 10.1016/s0161-6420(02)01158-2.

  PMID: 12208703 RESULT

• Marsh N, Larsen EN, Ullman AJ, Mihala G, Cooke M, Chopra V, Ray-Barruel G, Rickard CM. Peripheral intravenous catheter infection and failure: A systematic review and meta-analysis. Int J Nurs Stud. 2024 Mar;151:104673. doi: 10.1016/j.ijnurstu.2023.104673. Epub 2023 Dec 9.

  PMID: 38142634 RESULT

• Wang W. Tolerability of hypertonic injectables. Int J Pharm. 2015 Jul 25;490(1-2):308-15. doi: 10.1016/j.ijpharm.2015.05.069. Epub 2015 May 29.

  PMID: 26027488 RESULT

• Guanche-Sicilia A, Sanchez-Gomez MB, Castro-Peraza ME, Rodriguez-Gomez JA, Gomez-Salgado J, Duarte-Climents G. Prevention and Treatment of Phlebitis Secondary to the Insertion of a Peripheral Venous Catheter: A Scoping Review from a Nursing Perspective. Healthcare (Basel). 2021 May 19;9(5):611. doi: 10.3390/healthcare9050611.

  PMID: 34069674 RESULT

• Liang Z, Li H, Hou X, Yang K, Lv K, Ma Y, Lu Y, Wu K, Wu H. Prospective study on the role of preoperative mannitol in capsulorhexis and reducing intraoperative complications in primary angle-closure disease surgery. J Int Med Res. 2025 Jan;53(1):3000605241310106. doi: 10.1177/03000605241310106.

  PMID: 39817367 RESULT

MeSH Terms

Conditions

Glaucoma, Angle-Closure; Ocular Hypertension

Condition Hierarchy (Ancestors)

Glaucoma; Eye Diseases

Study Officials

• Laiwen Lv, Master

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This was an open-label study because the use of an infusion warming device could not be concealed from participants or care providers during treatment delivery.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants were randomly assigned in a parallel manner to receive intravenous mannitol infusion either with an infusion warming device or without warming. Each participant was assigned to one study arm only.

Study Record Dates

• First Submitted: March 17, 2026
• First Posted: March 27, 2026
• Study Start: January 9, 2025
• Primary Completion: July 27, 2025
• Study Completion: July 27, 2025
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)