250 Participants Needed

Ice Therapy for Injection Site Pain

Recruiting at 1 trial location
SM
OA
JM
Overseen ByJade Moon, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Minnesota
Must be taking: Anti-VEGF

Trial Summary

What is the purpose of this trial?

Purpose: To examine the difference in patient's pain experience in the setting of intravitreal anti-VEGF injections with pretreatment of topical ice-therapy compared with no-ice.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Ice-therapy for reducing injection site pain?

Research shows that applying ice packs can effectively reduce pain during procedures like digital nerve blocks and skin grafts, making it a convenient and low-cost option for pain relief.12345

Is ice therapy safe for reducing pain at injection sites?

Ice therapy is generally considered safe for reducing pain at injection sites, as it has been used for many years to manage pain in various conditions. However, scientific evidence on its effectiveness is mixed, and it is important to follow recommended guidelines for its use.36789

How does ice therapy differ from other treatments for injection site pain?

Ice therapy is unique because it uses cold to numb the skin and reduce pain at the injection site, which is different from traditional methods like topical anesthetics that can have a longer duration and unpleasant taste. This method is simple, safe, and effective, especially for children and anxious patients.2371011

Research Team

JM

Jade Moon, MD

Principal Investigator

University of Minnesota

Eligibility Criteria

This trial is for adults 18 or older who need an anti-VEGF intravitreal injection for eye conditions, as determined by a retina specialist at the University of Minnesota Department of Ophthalmology. There are no specific exclusion criteria listed.

Inclusion Criteria

I am 18 or older and need an eye injection for my condition, as advised by a retina specialist.

Exclusion Criteria

N/A

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive intravitreal anti-VEGF injections with or without pretreatment of topical ice-therapy

1 day
1 visit (in-person)

Follow-up

Participants are monitored for pain, discomfort, burning, itching, and overall tolerability 24 hours after the injection

1 day
1 visit (virtual or phone call)

Treatment Details

Interventions

  • Ice-therapy
  • No Ice-therapy
Trial OverviewThe study is testing if applying ice on the skin (topical ice-therapy) before getting an eye injection can reduce pain compared to not using any ice. Patients' pain experiences with and without ice will be compared.
Participant Groups
2Treatment groups
Active Control
Placebo Group
Group I: Ice-therapyActive Control1 Intervention
Ice therapy will be provided prior to the provision of the intravitreal injection
Group II: No Ice-therapyPlacebo Group1 Intervention
No ice therapy will be provided prior to the provision of the intravitreal injection

Ice-therapy is already approved in United States, European Union, Canada for the following indications:

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Approved in United States as Topical Ice Compress for:
  • Pain management for intravitreal injections
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Approved in European Union as Ice Pack Therapy for:
  • Pain relief for ocular procedures
  • Local anesthesia for intravitreal injections
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Approved in Canada as Cold Compress Therapy for:
  • Pain management for eye injections
  • Anesthesia for minor ocular surgeries

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials
1,459
Recruited
1,623,000+

Findings from Research

Applying an ice pack for 6 minutes before a digital nerve block significantly reduces both needle stick and infiltration pain scores in patients with traumatic finger injuries, with scores dropping from 6.8 to 1.5 and from 8.5 to 2.7, respectively.
Patients who received the ice treatment reported higher satisfaction levels, indicating that using ice is an effective and simple method to enhance comfort during painful procedures like digital nerve blocks.
The assessment of ice pack effect in pain reduction during digital nerve block: A randomized clinical study.Rasooli, F., Sotoodehnia, M., Nejati, A., et al.[2020]
Cryotherapy, including methods like bagged ice and continuous cryotherapy devices, has been shown to reduce pain and analgesic consumption in about half of the studies reviewed, particularly after orthopedic surgeries, but its effectiveness in improving range of motion and reducing swelling is less clear.
Continuous cryotherapy devices appear to provide better outcomes in terms of pain reduction and recovery after knee arthroscopy compared to traditional ice methods, but more high-quality studies are needed to establish their superiority and safety as a standard treatment in orthopedic care.
Orthopaedic Application of Cryotherapy: A Comprehensive Review of the History, Basic Science, Methods, and Clinical Effectiveness.Kunkle, BF., Kothandaraman, V., Goodloe, JB., et al.[2023]
In a study involving 50 children aged 8-10, cryoanesthesia using tetrafluorethane spray was found to significantly reduce pain perception compared to traditional topical anesthetic lidocaine, as measured by the visual analog scale (VAS).
While both methods showed lower pain scores, the objective assessment using the sound, eye, and motor (SEM) scale indicated that tetrafluorethane was effective in reducing discomfort, suggesting it could be a better alternative for managing pain during local anesthesia in children.
Effectiveness of precooling the injection site using tetrafluorethane on pain perception in children.Hameed, NN., Sargod, SS., Bhat, SS., et al.[2022]

References

The assessment of ice pack effect in pain reduction during digital nerve block: A randomized clinical study. [2020]
Orthopaedic Application of Cryotherapy: A Comprehensive Review of the History, Basic Science, Methods, and Clinical Effectiveness. [2023]
Effectiveness of precooling the injection site using tetrafluorethane on pain perception in children. [2022]
Ice application to minimize pain in the split-thickness skin graft donor site. [2008]
Effect of ice on pain after corticosteroid injection in the hand and wrist: a randomized controlled trial. [2017]
A study protocol for a randomised controlled trial of ice to reduce the pain of immunisation: The ICE trial. [2022]
Cold therapy and its effect on procedural pain in children. [2019]
Ice freezes pain? A review of the clinical effectiveness of analgesic cold therapy. [2022]
Ice therapy: cool, current and complicated. [2020]
10.United Statespubmed.ncbi.nlm.nih.gov
Topical ice: a precursor to palatal injections. [2008]
Cooling the soft tissue and its effect on perception of pain during infiltration and block anesthesia in children undergoing dental procedures: A comparative study. [2020]