<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04441762</url>
  </required_header>
  <id_info>
    <org_study_id>InkArc2020</org_study_id>
    <nct_id>NCT04441762</nct_id>
  </id_info>
  <brief_title>Atomized Intranasal Vs Intravenous Ketorolac in Acute Renal Colic Pain Management.</brief_title>
  <acronym>Ink-Arc</acronym>
  <official_title>Atomized Intranasal Vs Intravenous Ketorolac in Acute Renal Colic Pain Management: A Randomized Controlled Double-blinded Clinical Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oman Medical Speciality Board</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Oman Medical Speciality Board</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Introduction: Pain is a common reason for individuals to seek health care, especially&#xD;
      emergency care. Ketorolac has numerous advantages over other pain medications, especially the&#xD;
      opioids. The intranasal administration of ketorolac has been shown to be safe and effective&#xD;
      in the treatment of postoperative pain following major abdominal surgery and post dental&#xD;
      surgery, but there have been no studies evaluating the use of intranasal ketorolac for the&#xD;
      treatment of acute renal colic pain in the emergency department.&#xD;
&#xD;
      Methods: This is a double blinded randomized controlled trial. two hundred renal colic&#xD;
      patients presented to the emergency department will be randomized to intervention (30 mg&#xD;
      intranasal ketorolac) and (30mg intravenous ketorolac) case groups. Their pain before and&#xD;
      after receiving ketorolac will be measured by visual Analog Scale (VAS pain score). Patient,&#xD;
      attending physician and administering nurse will be blinded throughout the study. The&#xD;
      analgesic effects will be assessed by several measures including pain relief, pain intensity&#xD;
      difference, global pain evaluation, global assessment of analgesia, and the summed pain&#xD;
      intensity difference. The safety will be assessed by documentation of adverse events, vital&#xD;
      signs, and clinical assessment before and after drug administration.&#xD;
&#xD;
      Aim: The aim of this study is to compare analgesic effects of intranasal Ketorolac&#xD;
      tromethamine versus intravenous Ketorolac tromethamine in adult patients with moderate to&#xD;
      severe renal colic.&#xD;
&#xD;
      Primary Objective: Analgesic effects of Intranasal Ketorolac on the visual analog scale&#xD;
      (VAS).&#xD;
&#xD;
      Secondary Objectives: Adverse Events, the need of rescue pain medications, time to discharge&#xD;
      and recurrent visit within 24 hours.&#xD;
&#xD;
      Patient Population: Adults (from age 18 to 64 years) who presents to emergency department&#xD;
      (ED) at Sultan Qaboos University Hospital with moderate to severe acute flank pain suggestive&#xD;
      of renal colic (visual analog scale 7 or more).&#xD;
&#xD;
      Intervention: Single dose of intranasal ketorolac 30mg.&#xD;
&#xD;
      Clinical measurement: Visual Analog Scale will be assessed at 0, 30 and 60 minutes after&#xD;
      intervention. Number and dosage of rescue medication, any reported events by patient or&#xD;
      attending physician will be documented.&#xD;
&#xD;
      Outcome: Decrease in pain measures by VAS pain score after intranasal ketorolac is given,&#xD;
      tolerability and safety evaluation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Research objectives and hypothesis:&#xD;
&#xD;
      The aim of this study is to compare the analgesic effects of intranasal Ketorolac&#xD;
      tromethamine versus intravenous Ketorolac tromethamine in adult patients with moderate to&#xD;
      severe renal colic seen at the Emergency Department at Sultan Qaboos University Hospital.&#xD;
&#xD;
      Study design:&#xD;
&#xD;
      Prospective double-blinded randomized clinical trial in adults (from age 18 to 64 years) who&#xD;
      presents to the emergency department (ED) at Sultan Qaboos University Hospital with moderate&#xD;
      to severe acute flank pain suggestive of renal colic (visual analog scale 7 or more). Written&#xD;
      consent will be obtained from the patient. Eligible subjects will be enrolled (see section&#xD;
      5).&#xD;
&#xD;
      Control Group Will receive 30 mg intravenous ketorolac in 10 ml syringe + 1 ml Normal Saline&#xD;
      9% using the intranasal device (0.5 ml in each nostril).&#xD;
&#xD;
      Intervention Group Will receive 30 mg intranasal ketorolac in 1 ml intranasal device (0.5 ml&#xD;
      in each nostril) + 10 ml Intravenous Normal Saline 9%.&#xD;
&#xD;
      Primary endpoint:&#xD;
&#xD;
      Analgesic effects of Intranasal Ketorolac on the visual analog scale (VAS). Change in visual&#xD;
      analog scale after receiving intranasal ketorolac. 0 (no pain) - 10 (worst possible pain).&#xD;
&#xD;
      Secondary endpoint:&#xD;
&#xD;
        -  Adverse Event/Side Effects.&#xD;
&#xD;
        -  Safety assessed by reporting all adverse events.&#xD;
&#xD;
        -  The need of rescue pain medications.&#xD;
&#xD;
        -  Time to discharge.&#xD;
&#xD;
        -  Recurrent visit within 24 hours.&#xD;
&#xD;
      Sample size:&#xD;
&#xD;
      after 1 hour follow-up, 146 patient will be needed ( 73 on each arm) to have 90% power to&#xD;
      detect a difference of a 0.7 of the response of visual analog scale score ( which usually&#xD;
      ranges between 0 and 10 ) between the groups (5.3 vs 4.6) at the 5% alpha (significance)&#xD;
      level. Because of missing data and losses to follow-up, an additional 54 subjects will be&#xD;
      needed (100 in each arm) for a total of 200 subjects (study sample). A P-value &lt;0.5. Level of&#xD;
      significance to be used.&#xD;
&#xD;
      Study Procedures:&#xD;
&#xD;
        1. Present to the Clinical Site Adult subjects ages 18 to 64 years with a classical&#xD;
           presentation of acute renal colic being seen in the emergency department may be eligible&#xD;
           for this study.&#xD;
&#xD;
           Clinical sign and symptoms&#xD;
&#xD;
             -  Severe flank pain radiating inferiorly and anteriorly with or without:&#xD;
&#xD;
             -  Nausea and vomiting.&#xD;
&#xD;
             -  Urinary symptoms.&#xD;
&#xD;
             -  Previous history of renal colic.&#xD;
&#xD;
        2. Eligibility Assessments Inclusion and exclusion criteria will be check.&#xD;
&#xD;
        3. Informed Consent Potentially eligible participants will be identified by their treating&#xD;
           clinicians. Written informed consent to participate in this study will follow a process&#xD;
           of information exchange between clinicians and potential participants.&#xD;
&#xD;
        4. Study Pain Assessments&#xD;
&#xD;
           Three pain assessments will be done based on VAS-Pain at:&#xD;
&#xD;
             -  0 minutes&#xD;
&#xD;
             -  30 minutes&#xD;
&#xD;
             -  60 minutes Pain scores will be recorded and documented before the administration of&#xD;
                medication for a baseline pain assessment and at specified intervals after the&#xD;
                administration. Post-treatment pain scores will be recorded at 0, 30 and 60&#xD;
                minutes. Pain assessments will be by the Visual Analog Scale for Pain. It is&#xD;
                usually presented as a 10cm horizontal line on which the patient's pain intensity&#xD;
                is represented by a point between the extremes of &quot;no pain at all&quot; and &quot;worst pain&#xD;
                imaginable.&quot; All patients must have a minimum of two pain scores. If rescue&#xD;
                medications were given, a VAS-Pain will be obtained immediately prior to treatment.&#xD;
&#xD;
        5. Standard-of-Care Procedures: Pain Management Patients may receive additional medications&#xD;
           as part of their emergency department treatment including additional pain medications,&#xD;
           such as opioids. Any additional medications administered will be recorded. The need for&#xD;
           additional medications (including the drug administered, the dose, the time, and the&#xD;
           route of administration) will be recorded.&#xD;
&#xD;
        6. Safety Assessments All adverse events will be documented on an adverse event case log.&#xD;
           Serious adverse events should be immediately reported to the primary investigator. Any&#xD;
           serious, adverse event will be reported immediately to the Institutional Review Board.&#xD;
&#xD;
      Adverse Events is considered serious if it causes a threat to the patient's life or&#xD;
      functioning. The U.S. Food and Drug Administration (FDA) defines a serious adverse event&#xD;
      (SAE) as any untoward medical occurrence that:&#xD;
&#xD;
        -  Results in death.&#xD;
&#xD;
        -  Life-threatening (places the patient at risk of death).&#xD;
&#xD;
        -  Requires hospitalization or prolongs an existing hospitalization.&#xD;
&#xD;
        -  Causes persistent or significant disability or incapacity.&#xD;
&#xD;
        -  Requires medical intervention to prevent one of the above outcomes.&#xD;
&#xD;
      RISKS AND BENEFITS Ketorolac has been proven effective for pain relief, especially for&#xD;
      certain types of pain, such as musculoskeletal pain, headaches and the pain from renal colic.&#xD;
      Inappropriate patients, ketorolac is a relatively safe drug for the treatment of pain. Side&#xD;
      effects and complications, such as gastrointestinal complaints (e.g. abdominal pain,&#xD;
      dyspepsia, GI bleeding) and renal dysfunction (elevation of the blood urea nitrogen and&#xD;
      creatinine) have been reported but with appropriate patient's selection are uncommon or rare.&#xD;
      The use of NSAIDS including ketorolac is not recommended in patients with active peptic ulcer&#xD;
      disease, renal disease or at risk for renal failure due to volume depletion, cerebrovascular&#xD;
      bleeding, hemorrhagic disorders, or those with a high risk of bleeding. With an appropriate&#xD;
      patient selection, ketorolac can be a safe and effective medication for the relief of pain.&#xD;
      The drug used in this study has a very low risk of developing any complications. However,&#xD;
      during visits patients will be monitored for any complications and all adverse effects if any&#xD;
      will be reported. With the proposed hypothesis, intranasal has the potential to reduce opioid&#xD;
      use in the ED, provides fast, needleless and easy methods to apply. It will decrease the&#xD;
      waiting time, cannulation and unnecessary blood investigations in patients with a classic&#xD;
      presentation of acute renal colic.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 30, 2020</start_date>
  <completion_date type="Actual">February 1, 2022</completion_date>
  <primary_completion_date type="Actual">February 1, 2022</primary_completion_date>
  <phase>Phase 2/Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>case-control trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Analgesic effects of Intranasal Ketorolac on the visual analog scale (VAS)</measure>
    <time_frame>At 30 and 60 minutes</time_frame>
    <description>Change in visual analog scale after receiving intranasal ketorolac. 0 (no pain) - 10 (worst possible pain).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adverse Events/Side Effects.</measure>
    <time_frame>48 hours</time_frame>
    <description>Any reported adverse events reported by subjects or attending doctor</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The need of rescue pain medications.</measure>
    <time_frame>60 min During Emergency Visit</time_frame>
    <description>After 60 min , patients can have rescue medications as standard of care.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to discharge.</measure>
    <time_frame>within 24 hours.</time_frame>
    <description>The time since first dose of Ketorolac to ED discharge.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recurrent visit</measure>
    <time_frame>within 24 hours.</time_frame>
    <description>Any recurrent visit with acute renal colic complaint</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">171</enrollment>
  <condition>Acute Renal Colic</condition>
  <arm_group>
    <arm_group_label>intravenous</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>30 mg intravenous ketorolac in 10 ml syringe + 1 mL Normal Saline 9% using an intranasal device (0.5 ml in each nostril).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intranasal</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>30 mg intranasal ketorolac in 1 ml intranasal device (0.5 ml in each nostril) + 10 ml Intravenous Normal Saline 9%.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Intravenous Ketorolac Tromethamine</intervention_name>
    <description>30 mg ketorolac single dose</description>
    <arm_group_label>intravenous</arm_group_label>
    <other_name>ketorolac injection</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Intranasal Ketorolac Tromethamine</intervention_name>
    <description>30 mg ketorolac single dose</description>
    <arm_group_label>Intranasal</arm_group_label>
    <other_name>Atomized Intranasal Ketorolac</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient with classical acute renal colic symptoms.&#xD;
&#xD;
          -  Age ≥ 18 years and &lt; 65 years&#xD;
&#xD;
          -  Stable patient with stable vital signs.&#xD;
&#xD;
          -  Mentally competent patient who can understand and sign the consent form.&#xD;
&#xD;
          -  Pain score is moderate to severe (visual analog scale 7 or more).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who are allergic to ketorolac.&#xD;
&#xD;
          -  Patients with active peptic ulcer disease.&#xD;
&#xD;
          -  Patients with a history of asthma, urticaria, or other allergic-type reactions after&#xD;
             taking NSAIDs.&#xD;
&#xD;
          -  Patients with renal disease and renal transplant.&#xD;
&#xD;
          -  Patients who are at risk for renal failure due to volume depletion.&#xD;
&#xD;
          -  Pregnant or nursing mothers.&#xD;
&#xD;
          -  Patients with any other contraindication to the use of ketorolac, or in whom the use&#xD;
             of ketorolac would not be consistent with the approved package insert.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Usama Al-Khalasi</last_name>
    <role>Principal Investigator</role>
    <affiliation>Oman Medical Speciality Board</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sultan Qaboos University Hospital</name>
      <address>
        <city>Muscat</city>
        <state>Aseeb</state>
        <zip>123</zip>
        <country>Oman</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Oman</country>
  </location_countries>
  <reference>
    <citation>Arhami Dolatabadi A, Memary E, Kariman H, Nasiri Gigloo K, Baratloo A. Intranasal Desmopressin Compared with Intravenous Ketorolac for Pain Management of Patients with Renal Colic Referring to the Emergency Department: A Randomized Clinical Trial. Anesth Pain Med. 2017 Feb 25;7(2):e43595. doi: 10.5812/aapm.43595. eCollection 2017 Apr.</citation>
    <PMID>28824859</PMID>
  </reference>
  <results_reference>
    <citation>Yazdani J, Khorshidi-Khiavi R, Nezafati S, Mortazavi A, Farhadi F, Nojan F, Ghanizadeh M. Comparison of analgesic effects of intravenous and intranasal ketorolac in patients with mandibular fracture-A Randomized Clinical Trial. J Clin Exp Dent. 2019 Sep 1;11(9):e768-e775. doi: 10.4317/jced.55753. eCollection 2019 Sep.</citation>
    <PMID>31636867</PMID>
  </results_reference>
  <results_reference>
    <citation>Singla N, Singla S, Minkowitz HS, Moodie J, Brown C. Intranasal ketorolac for acute postoperative pain. Curr Med Res Opin. 2010 Aug;26(8):1915-23. doi: 10.1185/03007995.2010.495564. Erratum In: Curr Med Res Opin. 2012 Jun;28(6):1052.</citation>
    <PMID>20557145</PMID>
  </results_reference>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>June 18, 2020</study_first_submitted>
  <study_first_submitted_qc>June 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 22, 2020</study_first_posted>
  <last_update_submitted>February 7, 2022</last_update_submitted>
  <last_update_submitted_qc>February 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Oman Medical Speciality Board</investigator_affiliation>
    <investigator_full_name>Usama Al-Khalasi</investigator_full_name>
    <investigator_title>Emergency Medicine Resident</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colic</mesh_term>
    <mesh_term>Renal Colic</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ketorolac</mesh_term>
    <mesh_term>Ketorolac Tromethamine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04441762
org study id: InkArc2020
nct id: NCT04441762
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Introduction: Pain is a common reason for individuals to seek health care, especially
      emergency care. Ketorolac has numerous advantages over other pain medications, especially the
      opioids. The intranasal administration of ketorolac has been shown to be safe and effective
      in the treatment of postoperative pain following major abdominal surgery and post dental
      surgery, but there have been no studies evaluating the use of intranasal ketorolac for the
      treatment of acute renal colic pain in the emergency department.

      Methods: This is a double blinded randomized controlled trial. two hundred renal colic
      patients presented to the emergency department will be randomized to intervention (30 mg
      intranasal ketorolac) and (30mg intravenous ketorolac) case groups. Their pain before and
      after receiving ketorolac will be measured by visual Analog Scale (VAS pain score). Patient,
      attending physician and administering nurse will be blinded throughout the study. The
      analgesic effects will be assessed by several measures including pain relief, pain intensity
      difference, global pain evaluation, global assessment of analgesia, and the summed pain
      intensity difference. The safety will be assessed by documentation of adverse events, vital
      signs, and clinical assessment before and after drug administration.

      Aim: The aim of this study is to compare analgesic effects of intranasal Ketorolac
      tromethamine versus intravenous Ketorolac tromethamine in adult patients with moderate to
      severe renal colic.

      Primary Objective: Analgesic effects of Intranasal Ketorolac on the visual analog scale
      (VAS).

      Secondary Objectives: Adverse Events, the need of rescue pain medications, time to discharge
      and recurrent visit within 24 hours.

      Patient Population: Adults (from age 18 to 64 years) who presents to emergency department
      (ED) at Sultan Qaboos University Hospital with moderate to severe acute flank pain suggestive
      of renal colic (visual analog scale 7 or more).

      Intervention: Single dose of intranasal ketorolac 30mg.

      Clinical measurement: Visual Analog Scale will be assessed at 0, 30 and 60 minutes after
      intervention. Number and dosage of rescue medication, any reported events by patient or
      attending physician will be documented.

      Outcome: Decrease in pain measures by VAS pain score after intranasal ketorolac is given,
      tolerability and safety evaluation.
Research objectives and hypothesis:

      The aim of this study is to compare the analgesic effects of intranasal Ketorolac
      tromethamine versus intravenous Ketorolac tromethamine in adult patients with moderate to
      severe renal colic seen at the Emergency Department at Sultan Qaboos University Hospital.

      Study design:

      Prospective double-blinded randomized clinical trial in adults (from age 18 to 64 years) who
      presents to the emergency department (ED) at Sultan Qaboos University Hospital with moderate
      to severe acute flank pain suggestive of renal colic (visual analog scale 7 or more). Written
      consent will be obtained from the patient. Eligible subjects will be enrolled (see section
      5).

      Control Group Will receive 30 mg intravenous ketorolac in 10 ml syringe + 1 ml Normal Saline
      9% using the intranasal device (0.5 ml in each nostril).

      Intervention Group Will receive 30 mg intranasal ketorolac in 1 ml intranasal device (0.5 ml
      in each nostril) + 10 ml Intravenous Normal Saline 9%.

      Primary endpoint:

      Analgesic effects of Intranasal Ketorolac on the visual analog scale (VAS). Change in visual
      analog scale after receiving intranasal ketorolac. 0 (no pain) - 10 (worst possible pain).

      Secondary endpoint:

        -  Adverse Event/Side Effects.

        -  Safety assessed by reporting all adverse events.

        -  The need of rescue pain medications.

        -  Time to discharge.

        -  Recurrent visit within 24 hours.

      Sample size:

      after 1 hour follow-up, 146 patient will be needed ( 73 on each arm) to have 90% power to
      detect a difference of a 0.7 of the response of visual analog scale score ( which usually
      ranges between 0 and 10 ) between the groups (5.3 vs 4.6) at the 5% alpha (significance)
      level. Because of missing data and losses to follow-up, an additional 54 subjects will be
      needed (100 in each arm) for a total of 200 subjects (study sample). A P-value <0.5. Level of
      significance to be used.

      Study Procedures:

        1. Present to the Clinical Site Adult subjects ages 18 to 64 years with a classical
           presentation of acute renal colic being seen in the emergency department may be eligible
           for this study.

           Clinical sign and symptoms

             -  Severe flank pain radiating inferiorly and anteriorly with or without:

             -  Nausea and vomiting.

             -  Urinary symptoms.

             -  Previous history of renal colic.

        2. Eligibility Assessments Inclusion and exclusion criteria will be check.

        3. Informed Consent Potentially eligible participants will be identified by their treating
           clinicians. Written informed consent to participate in this study will follow a process
           of information exchange between clinicians and potential participants.

        4. Study Pain Assessments

           Three pain assessments will be done based on VAS-Pain at:

             -  0 minutes

             -  30 minutes

             -  60 minutes Pain scores will be recorded and documented before the administration of
                medication for a baseline pain assessment and at specified intervals after the
                administration. Post-treatment pain scores will be recorded at 0, 30 and 60
                minutes. Pain assessments will be by the Visual Analog Scale for Pain. It is
                usually presented as a 10cm horizontal line on which the patient's pain intensity
                is represented by a point between the extremes of "no pain at all" and "worst pain
                imaginable." All patients must have a minimum of two pain scores. If rescue
                medications were given, a VAS-Pain will be obtained immediately prior to treatment.

        5. Standard-of-Care Procedures: Pain Management Patients may receive additional medications
           as part of their emergency department treatment including additional pain medications,
           such as opioids. Any additional medications administered will be recorded. The need for
           additional medications (including the drug administered, the dose, the time, and the
           route of administration) will be recorded.

        6. Safety Assessments All adverse events will be documented on an adverse event case log.
           Serious adverse events should be immediately reported to the primary investigator. Any
           serious, adverse event will be reported immediately to the Institutional Review Board.

      Adverse Events is considered serious if it causes a threat to the patient's life or
      functioning. The U.S. Food and Drug Administration (FDA) defines a serious adverse event
      (SAE) as any untoward medical occurrence that:

        -  Results in death.

        -  Life-threatening (places the patient at risk of death).

        -  Requires hospitalization or prolongs an existing hospitalization.

        -  Causes persistent or significant disability or incapacity.

        -  Requires medical intervention to prevent one of the above outcomes.

      RISKS AND BENEFITS Ketorolac has been proven effective for pain relief, especially for
      certain types of pain, such as musculoskeletal pain, headaches and the pain from renal colic.
      Inappropriate patients, ketorolac is a relatively safe drug for the treatment of pain. Side
      effects and complications, such as gastrointestinal complaints (e.g. abdominal pain,
      dyspepsia, GI bleeding) and renal dysfunction (elevation of the blood urea nitrogen and
      creatinine) have been reported but with appropriate patient's selection are uncommon or rare.
      The use of NSAIDS including ketorolac is not recommended in patients with active peptic ulcer
      disease, renal disease or at risk for renal failure due to volume depletion, cerebrovascular
      bleeding, hemorrhagic disorders, or those with a high risk of bleeding. With an appropriate
      patient selection, ketorolac can be a safe and effective medication for the relief of pain.
      The drug used in this study has a very low risk of developing any complications. However,
      during visits patients will be monitored for any complications and all adverse effects if any
      will be reported. With the proposed hypothesis, intranasal has the potential to reduce opioid
      use in the ED, provides fast, needleless and easy methods to apply. It will decrease the
      waiting time, cannulation and unnecessary blood investigations in patients with a classic
      presentation of acute renal colic.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: case-control trial
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Analgesic effects of Intranasal Ketorolac on the visual analog scale (VAS)
time frame: At 30 and 60 minutes
description: Change in visual analog scale after receiving intranasal ketorolac. 0 (no pain) - 10 (worst possible pain).
measure: Adverse Events/Side Effects.
time frame: 48 hours
description: Any reported adverse events reported by subjects or attending doctor
measure: The need of rescue pain medications.
time frame: 60 min During Emergency Visit
description: After 60 min , patients can have rescue medications as standard of care.
measure: Time to discharge.
time frame: within 24 hours.
description: The time since first dose of Ketorolac to ED discharge.
measure: Recurrent visit
time frame: within 24 hours.
description: Any recurrent visit with acute renal colic complaint
arm group label: intravenous
arm group type: Active Comparator
description: 30 mg intravenous ketorolac in 10 ml syringe + 1 mL Normal Saline 9% using an intranasal device (0.5 ml in each nostril).
arm group label: Intranasal
arm group type: Experimental
description: 30 mg intranasal ketorolac in 1 ml intranasal device (0.5 ml in each nostril) + 10 ml Intravenous Normal Saline 9%.
intervention type: Drug
intervention name: Intravenous Ketorolac Tromethamine
description: 30 mg ketorolac single dose
arm group label: intravenous
other name: ketorolac injection
intervention type: Drug
intervention name: Intranasal Ketorolac Tromethamine
description: 30 mg ketorolac single dose
arm group label: Intranasal
other name: Atomized Intranasal Ketorolac
criteria: 
gender: All
minimum age: 18 Years
maximum age: 64 Years
healthy volunteers: No
last name: Usama Al-Khalasi
role: Principal Investigator
affiliation: Oman Medical Speciality Board
facility: 
country: Oman
citation: Arhami Dolatabadi A, Memary E, Kariman H, Nasiri Gigloo K, Baratloo A. Intranasal Desmopressin Compared with Intravenous Ketorolac for Pain Management of Patients with Renal Colic Referring to the Emergency Department: A Randomized Clinical Trial. Anesth Pain Med. 2017 Feb 25;7(2):e43595. doi: 10.5812/aapm.43595. eCollection 2017 Apr.
PMID: 28824859
citation: Yazdani J, Khorshidi-Khiavi R, Nezafati S, Mortazavi A, Farhadi F, Nojan F, Ghanizadeh M. Comparison of analgesic effects of intravenous and intranasal ketorolac in patients with mandibular fracture-A Randomized Clinical Trial. J Clin Exp Dent. 2019 Sep 1;11(9):e768-e775. doi: 10.4317/jced.55753. eCollection 2019 Sep.
PMID: 31636867
citation: Singla N, Singla S, Minkowitz HS, Moodie J, Brown C. Intranasal ketorolac for acute postoperative pain. Curr Med Res Opin. 2010 Aug;26(8):1915-23. doi: 10.1185/03007995.2010.495564. Erratum In: Curr Med Res Opin. 2012 Jun;28(6):1052.
PMID: 20557145
responsible party type: Principal Investigator
investigator affiliation: Oman Medical Speciality Board
investigator full name: Usama Al-Khalasi
investigator title: Emergency Medicine Resident
mesh term: Colic
mesh term: Renal Colic
mesh term: Ketorolac
mesh term: Ketorolac Tromethamine
sharing ipd: No