OBJECTIVES: The objective of this study was to test the hypothesis that topical tetracaine would be safe to use for 24 hours and would not affect corneal healing, that patients would experience more pain relief, and that patients would perceive tetracaine to be more effective than saline eye drops for the treatment of pain caused by corneal abrasions. METHODS: The study was a 12-month, prospective, double-blind, randomized trial of tetracaine versus saline set in the emergency department (ED) of a regional tertiary care teaching hospital. A total of 116 patients presenting with uncomplicated corneal abrasions were included in this study. The intervention was either undiluted, preservative-free, topical tetracaine hydrochloride 1% or saline, applied up to every 30 minutes while awake for 24 hours. Main safety outcome measures were repeat ED examinations at 48 hours with fluorescein staining and slit-lamp examination, 1-week and 1-month telephone interviews with additional examinations as needed, and monitoring of charts for complications. Secondary outcome measures were 100-mm visual analogue scale (VAS) pain scores recorded every 2 hours while awake for 48 hours and patient-perceived overall effectiveness using a numeric rating scale (NRS) of 0 to 10 obtained during telephone interviews. RESULTS: At least one follow-up encounter was completed on each of the 116 patients. No complications specifically attributed to topical anesthetic use occurred in the 59 patients in the tetracaine group, and the binomial probability confidence interval (CI) of this occurring is 0 to 6.1. There was no significant difference in corneal healing as measured by the percentage of patients with persistent fluorescein uptake at 48 hours between the two groups (23.9% vs. 21.3%, difference=2.6%, 95% CI=-14% to 20%, p=0.761) or persistent symptoms at 48 hours (21.7% vs. 21.3%, difference=0.4%, 95% CI=-16% to 17%, p=0.957). There was no clinical difference in VAS pain scores between the groups. Patients in the tetracaine group rated the study drugs' overall effectiveness significantly higher on the NRS (7.7 vs. 3.9) compared to patients in the saline group (difference=3.9, 95% CI=2.4 to 5.3, p<0.0005). CONCLUSIONS:Topical tetracaine used for 24 hours is safe, and while there was no significant difference in patient VAS pain ratings over time, patient surveys on overall effectiveness showed that patients perceived tetracaine to be significantly more effective than saline.
RCT Entities:
OBJECTIVES: The objective of this study was to test the hypothesis that topical tetracaine would be safe to use for 24 hours and would not affect corneal healing, that patients would experience more pain relief, and that patients would perceive tetracaine to be more effective than saline eye drops for the treatment of pain caused by corneal abrasions. METHODS: The study was a 12-month, prospective, double-blind, randomized trial of tetracaine versus saline set in the emergency department (ED) of a regional tertiary care teaching hospital. A total of 116 patients presenting with uncomplicated corneal abrasions were included in this study. The intervention was either undiluted, preservative-free, topical tetracaine hydrochloride 1% or saline, applied up to every 30 minutes while awake for 24 hours. Main safety outcome measures were repeat ED examinations at 48 hours with fluorescein staining and slit-lamp examination, 1-week and 1-month telephone interviews with additional examinations as needed, and monitoring of charts for complications. Secondary outcome measures were 100-mm visual analogue scale (VAS) pain scores recorded every 2 hours while awake for 48 hours and patient-perceived overall effectiveness using a numeric rating scale (NRS) of 0 to 10 obtained during telephone interviews. RESULTS: At least one follow-up encounter was completed on each of the 116 patients. No complications specifically attributed to topical anesthetic use occurred in the 59 patients in the tetracaine group, and the binomial probability confidence interval (CI) of this occurring is 0 to 6.1. There was no significant difference in corneal healing as measured by the percentage of patients with persistent fluorescein uptake at 48 hours between the two groups (23.9% vs. 21.3%, difference=2.6%, 95% CI=-14% to 20%, p=0.761) or persistent symptoms at 48 hours (21.7% vs. 21.3%, difference=0.4%, 95% CI=-16% to 17%, p=0.957). There was no clinical difference in VAS pain scores between the groups. Patients in the tetracaine group rated the study drugs' overall effectiveness significantly higher on the NRS (7.7 vs. 3.9) compared to patients in the saline group (difference=3.9, 95% CI=2.4 to 5.3, p<0.0005). CONCLUSIONS: Topical tetracaine used for 24 hours is safe, and while there was no significant difference in patient VAS pain ratings over time, patient surveys on overall effectiveness showed that patients perceived tetracaine to be significantly more effective than saline.