Toradol to Reduce Ureteroscopic Symptoms Trial
Condition: Urinary Lithiasis; Kidney Diseases; Kidney Stone; Pain, Postoperative
MeSH terms: Kidney Diseases; Kidney Calculi; Urolithiasis; Urinary Calculi; Pain, Postoperative; Lithiasis
Study type: Interventional
Phase: Phase 2

Summary: 
      Double blinded randomized controlled clinical trial to assess the impact of intraoperative
      Toradol on post-operative pain scores for patients undergoing ureteroscopy for urinary stone
      management.
    

Detailed description: 
      This is an investigator-initiated, single-center, prospective randomized clinical trial
      evaluating the efficacy of intraoperative Ketorolac on post-operative pain in patients
      undergoing ureteroscopy at Yale-New Haven Hospital.

      The study population will include anyone between the age of 18-80 who is undergoing elective
      ureteroscopy for management of stone disease without contraindication to ketorolac.

      Patients who are being consented to undergo a ureteroscopy with the PI will be asked to
      participate in this study. There is currently no consensus on standard of care regarding
      intraoperative analgesia for ureteroscopy. There is wide variability in practice, some
      clinicians choose to administer intraoperative analgesia while others rely only on the
      sedation effects of general anesthesia. This study is being carried out to see if
      administration of Ketorolac during ureteroscopy provides a post-operative benefit in pain
      scores when compared to no treatment.

      The intervention group in this study will receive a one-time dose of Ketorolac 30mg
      intravenously after undergoing general anesthesia. Because participants will be under general
      anesthesia, participants will not know if they received the medication. Following the
      procedure, the intervention group may continue to use Ketorolac as needed to manage pain. The
      only difference between the intervention group and the non-intervention group is the one time
      dose of intraoperative ketorolac.

      The FDA approves Ketorolac as a nonsteroidal anti-inflammatory drug (NSAID), indicated for
      the short-term (up to 5 days in adults) management of moderately severe acute pain that
      requires analgesia at the opioid level.

      Following assessment of eligibility and documentation of consent to participate in the study,
      participants will be randomized to receive intraoperative Ketorolac Tromethamine (Toradol®)
      or not. In the no-treatment group, participants will not receive a dose of intra-operative
      Ketorolac. Pain will be managed in the standard way with post-operative Ketorolac as needed.
      In the treatment group, participants will receive one dose of Ketorolac IV 30mg during the
      procedure. Randomization will occur by the attending anesthesiologist.

      For this trial, the investigators, surgical team, and patients will be blinded to the
      administration of the agent, which is given as an IV Push of 30mg. For patients who are older
      than 65 years or weight less than 50kg, the dose will be adjusted to 15mg to minimize the
      risk of bleeding. The anesthesiologist will not be blinded as he/she will deliver the agent
      and because the use of ketorolac may alter their usage of other intra-operative agents and
      post-operative agents. The surgical team will be un-blinded post-operatively.

      Following the procedure, participants will rate their pain using a visual pain assessment
      scale at 1 hour postoperatively and at the time of discharge from the recovery room. Once the
      patient is at home, the participant will fill out a validated survey that has questions
      related to pain. This will be filled out once a day for a total of 7 days following the
      procedure. In addition, the investigators will provide a medication utilization diary sheet
      for the participant to record daily use of prescribed narcotic and other as needed over the
      counter medications such as acetaminophen and ibuprofen.This will also be done daily for a
      total of 7 days. The participant will be surveyed at a one-week postoperative visit using the
      same assessment. All adverse drug reactions will be recorded from the time of administration
      to initial follow-up.
    

Intervention name(s): Toradol
Intervention type(s): Drug
Intervention description(s): IV toradol
Intervention MeSH terms: Ketorolac Tromethamine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment