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The purpose of this study is to determine if local anesthetic, either a subtenons injection (an injection just beneath the surface tissue of the eye) or a topical ophthalmic gel (applied directly on the surface of the eye) given at the end of strabismus surgery reduces postoperative pain. Some surgeons routinely use either the subtenon and/or topical anesthetic for pain at the end of strabismus surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| subtenons anesthetic and topical control | Other | Group 1 (subtenons anesthetic and topical control): 0.5 cc of local anesthetic (preservative-free bupivacaine 0.75%) administered via a cannula subtenons through each surgical wound with 0.5 cc of Hypromellose 0.3% gel applied topically to each surgical wound at end of surgery |
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| topical anesthetic and subtenons control | Other | Group 2 (topical anesthetic and subtenons control): 0.5 cc of lidocaine 3.5% ophthalmic gel applied topically to each surgical wound and 0.5 cc of normal saline (NS) administered via a cannula subtenons through each surgical wound at end of surgery |
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| topical control and subtenons control | Other | Group 3 (topical control and subtenons control): 0.5 cc of topical Hypromellose 0.3% gel applied topically to each surgical wound and 0.5 cc of NS administered via a cannula subtenons through each surgical wound at end of surgery |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| subtenons anesthetic - preservative-free bupivacaine 0.75% | Drug |
| ||
| topical anesthetic - 0.5 cc of lidocaine 3.5% ophthalmic gel |
| Measure | Description | Time Frame |
|---|---|---|
| Average Pain Score Over the First 30 Post-operative Minutes Using the CHEOPS Scale | Pain will be assessed by a masked observer using the Children's Hospital Eastern Ontario Pain Scale (CHEOPS) scale. The CHEOPS (Children's Hospital of Eastern Ontario Pain Scale) is a behavioral scale for evaluating postoperative pain in young children. The scale is assessed using the sum of a score for cry (1-3), facial expression (0-2), verbalization (0-2), torso (1-2), touch (1-2) and legs (1-2). The minimum score is 4, the maximum score is 13, and higher scores indicate more pain. Pain is rated every 5 minutes for the first 30 minutes postoperatively. Each pain score collected in the first 30 minutes was averaged to calculate a per per participant average pain score over the first 30 minutes . Then each participant's per participant average pain score was combined to calculate the reported mean for "Average pain score over the first 30 post-operative minutes using the CHEOPS scale." for each group. | 0-30 minutes post-operative |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Pain Score | This secondary outcome will include the peak pain score for duration of follow up period. Pain will be assessed by masked observers, using the CHEOPS scale. The CHEOPS (Children's Hospital of Eastern Ontario Pain Scale) is a behavioral scale for evaluating postoperative pain in young children. The scale is assessed using the sum of a score for cry (1-3), facial expression (0-2), verbalization (0-2), torso (1-2), touch (1-2) and legs (1-2). The minimum score is 4, the maximum score is 13, and higher scores indicate more pain. A pain score was assessed and recorded every 5 minutes by a masked observer (clinical research coordinator) for the first 30 minutes after extubation, then every 15 minutes for the next hour, then, if applicable, hourly until discharge. |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laura Enyedi, MD | Duke Eye Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke Eye Center | Durham | North Carolina | 27710 | United States |
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57 participants signed consent. 7 participants were withdrawn by PI prior to randomization.
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| ID | Title | Description |
|---|---|---|
| FG000 | Subtenons Anesthetic and Topical Control | Group 1 (subtenons anesthetic and topical control): 0.5 cc of local anesthetic (preservative-free bupivacaine 0.75%) administered via a cannula subtenons through each surgical wound with 0.5 cc of Hypromellose 0.3% gel applied topically to each surgical wound at end of surgery subtenons anesthetic - preservative-free bupivacaine 0.75% topical control - 0.5 cc of Hypromellose 0.3% gel |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Drug |
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| topical control - 0.5 cc of Hypromellose 0.3% gel | Drug |
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| subtenons control - 0.5 cc of Normal Saline | Drug |
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| 0-150 minutes post-operative |
| Total Narcotic Use During Post-operative Recovery | This secondary outcome will include total narcotic use | Total time in post-operative recovery - up to 6 hours |
| Negative Postoperative Behavior Score on the PHBQ (Post Hospitalization Behavioral Questionnaire) | This secondary outcome will determine the negative postoperative behaviors based on the PHBQ questionnaire given to the parents of the child 1 week (+/- 3 days) post-operatively. with a score of 81 indicating no change, a score of less than 81 indicating a change for the better, and a score of over 81 indicating a change for the worse, on average, in behavior. Lowest score 27; highest score 135 | 1 week (+/- 3 days) post operatively |
| Average Time to Discharge | 0-150 minutes post-operative |
| Number of Participants With Post Operative Nausea and Vomiting | 0-150 minutes post-operative |
| Number of Participants Who Required Anti-emetic Medication Post-operatively | Total time in post-operative recovery - up to 6 hours |
| Peak Pain Score During First 30 Minutes | This secondary outcome will include the peak pain score for duration of follow up period. Pain will be assessed by masked observers, using the CHEOPS scale. The CHEOPS (Children's Hospital of Eastern Ontario Pain Scale) is a behavioral scale for evaluating postoperative pain in young children. The scale is assessed using the sum of a score for cry (1-3), facial expression (0-2), verbalization (0-2), torso (1-2), touch (1-2) and legs (1-2). The minimum score is 4, the maximum score is 13, and higher scores indicate more pain. Pain is rated every 5 minutes for the first 30 minutes postoperatively. | 0-30 minutes post-operative |
| FG001 | Topical Anesthetic and Subtenons Control | Group 2 (topical anesthetic and subtenons control): 0.5 cc of lidocaine 3.5% ophthalmic gel applied topically to each surgical wound and 0.5 cc of normal saline (NS) administered via a cannula subtenons through each surgical wound at end of surgery topical anesthetic - 0.5 cc of lidocaine 3.5% ophthalmic gel subtenons control - 0.5 cc of Normal Saline |
| FG002 | Topical Control and Subtenons Control | Group 3 (topical control and subtenons control): 0.5 cc of topical Hypromellose 0.3% gel applied topically to each surgical wound and 0.5 cc of NS administered via a cannula subtenons through each surgical wound at end of surgery topical control - 0.5 cc of Hypromellose 0.3% gel subtenons control - 0.5 cc of Normal Saline |
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| ID | Title | Description |
|---|---|---|
| BG000 | Subtenons Anesthetic and Topical Control | Group 1 (subtenons anesthetic and topical control): 0.5 cc of local anesthetic (preservative-free bupivacaine 0.75%) administered via a cannula subtenons through each surgical wound with 0.5 cc of Hypromellose 0.3% gel applied topically to each surgical wound at end of surgery subtenons anesthetic - preservative-free bupivacaine 0.75% topical control - 0.5 cc of Hypromellose 0.3% gel |
| BG001 | Topical Anesthetic and Subtenons Control | Group 2 (topical anesthetic and subtenons control): 0.5 cc of lidocaine 3.5% ophthalmic gel applied topically to each surgical wound and 0.5 cc of normal saline (NS) administered via a cannula subtenons through each surgical wound at end of surgery topical anesthetic - 0.5 cc of lidocaine 3.5% ophthalmic gel subtenons control - 0.5 cc of Normal Saline |
| BG002 | Topical Control and Subtenons Control | Group 3 (topical control and subtenons control): 0.5 cc of topical Hypromellose 0.3% gel applied topically to each surgical wound and 0.5 cc of NS administered via a cannula subtenons through each surgical wound at end of surgery topical control - 0.5 cc of Hypromellose 0.3% gel subtenons control - 0.5 cc of Normal Saline |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | months |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Average Pain Score Over the First 30 Post-operative Minutes Using the CHEOPS Scale | Pain will be assessed by a masked observer using the Children's Hospital Eastern Ontario Pain Scale (CHEOPS) scale. The CHEOPS (Children's Hospital of Eastern Ontario Pain Scale) is a behavioral scale for evaluating postoperative pain in young children. The scale is assessed using the sum of a score for cry (1-3), facial expression (0-2), verbalization (0-2), torso (1-2), touch (1-2) and legs (1-2). The minimum score is 4, the maximum score is 13, and higher scores indicate more pain. Pain is rated every 5 minutes for the first 30 minutes postoperatively. Each pain score collected in the first 30 minutes was averaged to calculate a per per participant average pain score over the first 30 minutes . Then each participant's per participant average pain score was combined to calculate the reported mean for "Average pain score over the first 30 post-operative minutes using the CHEOPS scale." for each group. | Posted | Mean | Standard Deviation | units on a scale | 0-30 minutes post-operative |
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| Secondary | Peak Pain Score | This secondary outcome will include the peak pain score for duration of follow up period. Pain will be assessed by masked observers, using the CHEOPS scale. The CHEOPS (Children's Hospital of Eastern Ontario Pain Scale) is a behavioral scale for evaluating postoperative pain in young children. The scale is assessed using the sum of a score for cry (1-3), facial expression (0-2), verbalization (0-2), torso (1-2), touch (1-2) and legs (1-2). The minimum score is 4, the maximum score is 13, and higher scores indicate more pain. A pain score was assessed and recorded every 5 minutes by a masked observer (clinical research coordinator) for the first 30 minutes after extubation, then every 15 minutes for the next hour, then, if applicable, hourly until discharge. | Posted | Mean | Standard Deviation | units on a scale | 0-150 minutes post-operative |
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| Secondary | Total Narcotic Use During Post-operative Recovery | This secondary outcome will include total narcotic use | Posted | Mean | Standard Deviation | mcg/kg | Total time in post-operative recovery - up to 6 hours |
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| Secondary | Negative Postoperative Behavior Score on the PHBQ (Post Hospitalization Behavioral Questionnaire) | This secondary outcome will determine the negative postoperative behaviors based on the PHBQ questionnaire given to the parents of the child 1 week (+/- 3 days) post-operatively. with a score of 81 indicating no change, a score of less than 81 indicating a change for the better, and a score of over 81 indicating a change for the worse, on average, in behavior. Lowest score 27; highest score 135 | Posted | Mean | Standard Deviation | units on a scale | 1 week (+/- 3 days) post operatively |
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| Secondary | Average Time to Discharge | Posted | Mean | Standard Deviation | minutes | 0-150 minutes post-operative |
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| Secondary | Number of Participants With Post Operative Nausea and Vomiting | Posted | Number | participants | 0-150 minutes post-operative |
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| Secondary | Number of Participants Who Required Anti-emetic Medication Post-operatively | Posted | Number | participants | Total time in post-operative recovery - up to 6 hours |
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| Secondary | Peak Pain Score During First 30 Minutes | This secondary outcome will include the peak pain score for duration of follow up period. Pain will be assessed by masked observers, using the CHEOPS scale. The CHEOPS (Children's Hospital of Eastern Ontario Pain Scale) is a behavioral scale for evaluating postoperative pain in young children. The scale is assessed using the sum of a score for cry (1-3), facial expression (0-2), verbalization (0-2), torso (1-2), touch (1-2) and legs (1-2). The minimum score is 4, the maximum score is 13, and higher scores indicate more pain. Pain is rated every 5 minutes for the first 30 minutes postoperatively. | Posted | Mean | Standard Deviation | units on a scale | 0-30 minutes post-operative |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Subtenons Anesthetic and Topical Control | Group 1 (subtenons anesthetic and topical control): 0.5 cc of local anesthetic (preservative-free bupivacaine 0.75%) administered via a cannula subtenons through each surgical wound with 0.5 cc of Hypromellose 0.3% gel applied topically to each surgical wound at end of surgery subtenons anesthetic - preservative-free bupivacaine 0.75% topical control - 0.5 cc of Hypromellose 0.3% gel | 0 | 17 | 0 | 17 | ||
| EG001 | Topical Anesthetic and Subtenons Control | Group 2 (topical anesthetic and subtenons control): 0.5 cc of lidocaine 3.5% ophthalmic gel applied topically to each surgical wound and 0.5 cc of normal saline (NS) administered via a cannula subtenons through each surgical wound at end of surgery topical anesthetic - 0.5 cc of lidocaine 3.5% ophthalmic gel subtenons control - 0.5 cc of Normal Saline | 0 | 17 | 0 | 17 | ||
| EG002 | Topical Control and Subtenons Control | Group 3 (topical control and subtenons control): 0.5 cc of topical Hypromellose 0.3% gel applied topically to each surgical wound and 0.5 cc of NS administered via a cannula subtenons through each surgical wound at end of surgery topical control - 0.5 cc of Hypromellose 0.3% gel subtenons control - 0.5 cc of Normal Saline | 0 | 16 | 0 | 16 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Laura Enyedi, M.D. | Duke University Medical Center | 919-684-2038 | laura.enyedi@dm.duke.edu |
| ID | Term |
|---|---|
| D013285 | Strabismus |
| ID | Term |
|---|---|
| D015835 | Ocular Motility Disorders |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D005782 | Gels |
| ID | Term |
|---|---|
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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| Male |
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| OG002 | Topical Control and Subtenons Control | Group 3 (topical control and subtenons control): 0.5 cc of topical Hypromellose 0.3% gel applied topically to each surgical wound and 0.5 cc of NS administered via a cannula subtenons through each surgical wound at end of surgery topical control - 0.5 cc of Hypromellose 0.3% gel subtenons control - 0.5 cc of Normal Saline |
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| OG002 |
| Topical Control and Subtenons Control |
Group 3 (topical control and subtenons control): 0.5 cc of topical Hypromellose 0.3% gel applied topically to each surgical wound and 0.5 cc of NS administered via a cannula subtenons through each surgical wound at end of surgery topical control - 0.5 cc of Hypromellose 0.3% gel subtenons control - 0.5 cc of Normal Saline |
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| OG002 | Topical Control and Subtenons Control | Group 3 (topical control and subtenons control): 0.5 cc of topical Hypromellose 0.3% gel applied topically to each surgical wound and 0.5 cc of NS administered via a cannula subtenons through each surgical wound at end of surgery topical control - 0.5 cc of Hypromellose 0.3% gel subtenons control - 0.5 cc of Normal Saline |
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