Topical Ice-therapy for Pain Modulation During Intravitreal Injections: A Prospective Randomized Control Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Anesthesia; Hypothermia
- Sponsor
- University of Minnesota
- Enrollment
- 42
- Locations
- 1
- Primary Endpoint
- Overall Tolerability assessed by the visual analog scale
- Status
- Completed
- Last Updated
- 8 months ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •All patients aged 18 or older evaluated by a single retina specialist at the University of Minnesota Department of Ophthalmology with a clinical indication necessitating an anti-VEGF intravitreal injection
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Overall Tolerability assessed by the visual analog scale
Time Frame: This will be assessed at five minutes after the conclusion of the intravitreal injection
This primary outcome measure will be surveyed using a visual analog scale to quantify discomfort from a numerical level of one to ten. A self reported rating of one represents the lowest self-reported subjective rating attributed to overall tolerability, while a rating of ten signifies the maximum self-reported subjective rating attributed to overall tolerability.
Itching assessed by the visual analog scale
Time Frame: This will be assessed at five minutes after the conclusion of the intravitreal injection
This primary outcome measure will be surveyed using a visual analog scale to quantify discomfort from a numerical level of one to ten. A self reported rating of one represents the lowest self-reported subjective rating attributed to itching, while a rating of ten signifies the maximum self-reported subjective rating attributed to itching.
Discomfort assessed by the visual analog scale
Time Frame: This will be assessed at five minutes after the conclusion of the intravitreal injection
This primary outcome measure will be surveyed using a visual analog scale to quantify discomfort from a numerical level of one to ten. A self reported rating of one represents the lowest self-reported subjective rating attributed to discomfort, while a rating of ten signifies the maximum self-reported subjective rating attributed to discomfort.
Burning assessed by the visual analog scale
Time Frame: This will be assessed at five minutes after the conclusion of the intravitreal injection
This primary outcome measure will be surveyed using a visual analog scale to quantify discomfort from a numerical level of one to ten. A self reported rating of one represents the lowest self-reported subjective rating attributed to burning, while a rating of ten signifies the maximum self-reported subjective rating attributed to burning.
Overall Pain assessed by the visual analog scale
Time Frame: This will be assessed at five minutes after the conclusion of the intravitreal injection
This primary outcome measure will be surveyed using a visual analog scale to quantify discomfort from a numerical level of one to ten. A self reported rating of one represents the lowest self-reported subjective rating attributed to overall pain, while a rating of ten signifies the maximum self-reported subjective rating attributed to overall pain.
Secondary Outcomes
- Burning assessed by the visual analog scale(This will be assessed at 24-hours after the conclusion of the intravitreal injection)
- Discomfort assessed by the visual analog scale(This will be assessed at 24-hours after the conclusion of the intravitreal injection)
- Itching assessed by the visual analog scale(This will be assessed at 24-hours after the conclusion of the intravitreal injection)
- Overall Pain assessed by the visual analog scale(This will be assessed at 24-hours after the conclusion of the intravitreal injection)
- Overall Tolerability assessed by the visual analog scale(This will be assessed at 24-hours after the conclusion of the intravitreal injection)