Trial Outcomes & Findings for Toradol to Reduce Ureteroscopic Symptoms Trial (NCT NCT03111381)

NCT ID: NCT03111381

Last Updated: 2021-11-02

Results Overview

Once the patient is at home, they will fill out a validated visual analog pain scale to rate their pain. This will be filled out once a day for a total of 7 days following the procedure. This is total morphine equivalent use. The range is 0 to infinity. Higher scores are equated to worse pain. The units are "ME" or morphine equivalents.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 94 participants
• Primary outcome timeframe: up to 1 week
• Results posted on: 2021-11-02

Participant Flow

Participant milestones

Measure	Intervention Group The intervention group in this study will receive a one-time dose of Ketorolac 30mg intravenously after undergoing general anesthesia. Because the participants will be under general anesthesia, they will not know if they received the medication. The surgeon will also be blinded to this. The anesthesiologist will not be blinded as he/she will deliver the agent and because the use of Toradol may alter their usage of other intra-operative agents and post-operative agents Toradol: IV toradol	Non-Intervention Group In the no-treatment group, participants will not receive a dose of intra-operative Ketorolac.
Overall Study STARTED	46	48
Overall Study COMPLETED	46	48
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Intervention Group n=46 Participants The intervention group in this study will receive a one-time dose of Ketorolac 30mg intravenously after undergoing general anesthesia. Because the participants will be under general anesthesia, they will not know if they received the medication. The surgeon will also be blinded to this. The anesthesiologist will not be blinded as he/she will deliver the agent and because the use of Toradol may alter their usage of other intra-operative agents and post-operative agents Toradol: IV toradol	Non-Intervention Group n=48 Participants In the no-treatment group, participants will not receive a dose of intra-operative Ketorolac.	Total n=94 Participants Total of all reporting groups
Age, Continuous	33 years STANDARD_DEVIATION 147 • n=46 Participants	33 years STANDARD_DEVIATION 147 • n=48 Participants	33 years STANDARD_DEVIATION 146 • n=94 Participants
Sex: Female, Male Female	23 Participants n=46 Participants	22 Participants n=48 Participants	45 Participants n=94 Participants
Sex: Female, Male Male	23 Participants n=46 Participants	26 Participants n=48 Participants	49 Participants n=94 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: up to 1 week

Once the patient is at home, they will fill out a validated visual analog pain scale to rate their pain. This will be filled out once a day for a total of 7 days following the procedure.

This is total morphine equivalent use. The range is 0 to infinity. Higher scores are equated to worse pain. The units are "ME" or morphine equivalents.

Outcome measures

Measure	Intervention Group n=46 Participants The intervention group in this study will receive a one-time dose of Ketorolac 30mg intravenously after undergoing general anesthesia. Because the participants will be under general anesthesia, they will not know if they received the medication. The surgeon will also be blinded to this. The anesthesiologist will not be blinded as he/she will deliver the agent and because the use of Toradol may alter their usage of other intra-operative agents and post-operative agents Toradol: IV toradol	Non-Intervention Group n=48 Participants In the no-treatment group, participants will not receive a dose of intra-operative Ketorolac.
Post-operative Pain	22 milligram morphine equivalent Standard Deviation 14	30 milligram morphine equivalent Standard Deviation 18

SECONDARY outcome

Timeframe: 6 weeks post operative

Outcome measures

Measure	Intervention Group n=46 Participants The intervention group in this study will receive a one-time dose of Ketorolac 30mg intravenously after undergoing general anesthesia. Because the participants will be under general anesthesia, they will not know if they received the medication. The surgeon will also be blinded to this. The anesthesiologist will not be blinded as he/she will deliver the agent and because the use of Toradol may alter their usage of other intra-operative agents and post-operative agents Toradol: IV toradol	Non-Intervention Group n=48 Participants In the no-treatment group, participants will not receive a dose of intra-operative Ketorolac.
Number of Participants With Complications	6 Participants	4 Participants

Adverse Events

Intervention Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Non-Intervention Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jamil Syed

Yale Urology

Phone: 2037852815

Email: Jamil.syed@yale.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place