<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/NCT02985177</url>
  </required_header>
  <id_info>
    <org_study_id>99</org_study_id>
    <nct_id>NCT02985177</nct_id>
  </id_info>
  <brief_title>A RCT of a Combination of Analgesics for Pain Management in Children With a Suspected Fracture</brief_title>
  <acronym>CAST</acronym>
  <official_title>A Randomized Controlled Trial of a Combination of Analgesics for Pain Management in Children With a Suspected Fracture at Triage (CAST Trial)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St. Justine's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>St. Justine's Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      MSK-I is the most common cause for ED visits for children with pain, with a child's risk of&#xD;
      sustaining a fracture ranging from 27-42% by the age of 16 years. MSK-I is known to generate&#xD;
      moderate to severe pain in most children and the ED serves as the critical entry point for&#xD;
      these injured children. This study aims to provide rapid and sustained pain management for&#xD;
      children presenting with a MSK-I in the ED. The investigators will compare the efficacy of&#xD;
      two possible medication combinations of fentanyl intranasal (1.0 mcg/kg) + oral ibuprofen (10&#xD;
      mg/kg) and fentanyl intranasal (2.0 mcg/kg) + oral ibuprofen (10 mg/kg) for the rapid,&#xD;
      adequate and sustained pain management of children with suspected fracture.&#xD;
&#xD;
      The investigators believe that the combination of different dosage of intranasal fentanyl&#xD;
      with ibuprofen will lead to better pain treatment by providing a consistent and adequate&#xD;
      level of analgesia throughout the entire ED visit, including prior to physician exam and&#xD;
      during painful radiologic procedures.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pain management for children with a suspected fracture is suboptimal in the Emergency&#xD;
      Department (ED). This type of musculoskeletal injury (MSK-I) often generates moderate to&#xD;
      severe pain (&gt; 49 mm on 0 to 100 mm Visual Analogue Scale (VAS)), and requires rapid and&#xD;
      sustained pain management for the duration of the physical examination, diagnostic imaging&#xD;
      (X-Ray), immobilization and occasionally fracture reduction. Current standard care includes&#xD;
      the use of oral ibuprofen (IBU), a non-steroidal anti-inflammatory drug (NSAID), for&#xD;
      mild-to-moderate MSK-I pain in the ED. However, ibuprofen has been shown to be inadequate for&#xD;
      moderate-to-severe pain when used alone. A number of small/single centre studies suggest that&#xD;
      intranasal fentanyl (INF) is effective for rapidly decreasing MSK-I related pain in children&#xD;
      with a quick onset of 10 minutes and a peak action of 20 minutes. However, the duration of&#xD;
      its analgesic effect is limited to a maximum of 60 minutes, which does not provide an optimal&#xD;
      pain management for the duration of the ED stay, which typically lasts up to three hours.&#xD;
      Typically, patients with a fracture have sustained pain throughout their ED stay due to&#xD;
      imaging, splinting and repeated physical exams. Our objective is to examine the efficacy of a&#xD;
      combination of intranasal and oral analgesics for pain management in children presenting to&#xD;
      the ED with a suspected fracture. Our primary research question: For children presenting to&#xD;
      the ED with a suspected fracture, is a combination of INF1.0 (1.0 mcg/kg, maximum dose of 100&#xD;
      mcg) and IBU (10 mg/kg, maximum dose of 600 mg) more efficacious than a combination of INF2.0&#xD;
      (2.0 mcg/kg, maximum dose of 100 mcg) and oral ibuprofen (10 mg/kg, maximum dose of 600 mg)&#xD;
      to decrease pain at 15 minutes post-administration? Our primary hypothesis is: A combination&#xD;
      of INF2.0 and IBU will be more efficacious than a combination of INF1.0 and IBU to decrease&#xD;
      pain at 15 minutes post-administration.&#xD;
&#xD;
      Methods. Design: This study is a single-blind, two-arm, three-centre RCT of a combination of&#xD;
      analgesics for pain management of children presenting to the ED with a suspected fracture&#xD;
      will be performed. Settings: Children will be recruited in the following EDs: CHU&#xD;
      Sainte-Justine (Montreal, QC), Stollery Children's Hospital (Edmonton, AB), and Children's&#xD;
      Hospital of the London Health Sciences Centre (London, ON). Sample. Inclusion criteria: Will&#xD;
      be include children: (a) with a pain score &gt;49 mm on VAS at triage, (b) between the ages of 7&#xD;
      and 17 years, (c) presenting to the ED with a suspected fracture of the upper or lower limb,&#xD;
      and (d) who can communicate in either French or English. Exclusion criteria: Will be exclude&#xD;
      children with (a) known allergy to fentanyl or ibuprofen, (b) triage nurse suspicion of child&#xD;
      abuse, (c) inability to self-report pain, (d) chronic pain that necessitates daily analgesic&#xD;
      use, (e) NSAID or opioid analgesic use within the three hours prior to ED presentation, (f)&#xD;
      trauma to &gt;1 limb, (g) known hepatic or renal disease/dysfunction, (h) known bleeding&#xD;
      disorder, (i) neuro-cognitive disability that precludes assent and/or participating in the&#xD;
      study, (j) known history of obstructive sleep apnea (k) a suspected fracture of the nose, or&#xD;
      (l) significant head injury, as determined by the clinical team/triage nurse.&#xD;
&#xD;
      Allocation and Randomization: A biostatistician, independent to our study team, will generate&#xD;
      the randomization scheme that will consist of a computer-generated random listing of the&#xD;
      treatment using a 1:1 allocation scheme. Randomization will be stratified by center using&#xD;
      block-randomization (with permuted block sizes). Enrolled children will be allocated to (a)&#xD;
      INF 1.0 mcg/kg (up to a maximum of 100 mcg) via intranasal atomization + oral IBU 10 mg/kg&#xD;
      (up to a maximum of 600 mg) OR (b) INF 2.0 mcg/kg (up to a maximum of 100 mcg) via intranasal&#xD;
      atomization + oral IBU 10 mg/kg (up to a maximum of 600 mg.&#xD;
&#xD;
      Sample Size: Accounting for a 10% attrition rate, we determined that enrollment of 172&#xD;
      participants would provide at least 90 % power to detect a 10 mm absolute difference in mean&#xD;
      pain scores between groups at 15 minutes post-medication administration (T-15), at an alpha&#xD;
      level of 5 %.&#xD;
&#xD;
      Primary efficacy outcome: Mean difference in pain scores between groups at 15 minutes&#xD;
      post-medication administration (T-15) using the Visual Analogue Scale (VAS). Secondary&#xD;
      outcomes: (a) Mean differences in pain scores between groups at 30 min (T-30), 60 min (T-60),&#xD;
      90 min (T-90), 120 min (T-120) after medication administration, during the medical&#xD;
      examination (T-ME), and during radiographic procedure (T-XR), (b) the proportion of children&#xD;
      administered a rescue analgesic in the 60 minutes following administration of study&#xD;
      medication, (c) the proportion of children with adverse events at T-15, T-30, T-60, T-90,&#xD;
      T-120, T-ME and T-XR, (d) the proportion of children with serious adverse events at T-15,&#xD;
      T-30, T-60, T-90, T-120, T-ME and T-XR, (e) the proportion of children in each group with an&#xD;
      RSS score &gt; 3 (f) satisfaction of children and parents regarding pain management (T-120).&#xD;
&#xD;
      Relevance: In response to the persistent problem of inadequate and delayed analgesia, the&#xD;
      investigators believe that a combination of rapidly acting (INF) and longer-acting (oral&#xD;
      ibuprofen) medications will address both the delay in the time to effective analgesia and&#xD;
      overall under-treatment of suspected fracture pain. The team anticipate that an RCT&#xD;
      demonstrating the efficacy of a combination of fast and long-acting analgesics will&#xD;
      significantly improve the treatment for children with a suspected fracture in the ED. The&#xD;
      investigators hypothesize that use of INF2.0 and oral IBU will provide rapid pain relief that&#xD;
      is sustained for the duration of the ED visit. Promotion of adequate acute pain treatment of&#xD;
      children presenting to the ED will prevent the known short and long-term effects of&#xD;
      inadequately treated pain in children previously demonstrated by our team, including&#xD;
      unpleasant memories, stress and anxiety upon future visits to healthcare and compromised&#xD;
      functional outcomes such as missed school.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    We couldn't obtain funds for this study&#xD;
  </why_stopped>
  <start_date type="Anticipated">January 2020</start_date>
  <completion_date type="Anticipated">September 2021</completion_date>
  <primary_completion_date type="Anticipated">July 2021</primary_completion_date>
  <phase>Phase 4</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean difference in pain scores between groups</measure>
    <time_frame>15 minutes post-medication administration (T-15)</time_frame>
    <description>Measure: Visual Analogue Scale (VAS)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean difference in pain scores between groups</measure>
    <time_frame>30 min (T-30), 60 min (T-60), 90 min (T-90), 120 min (T-120) post-medication administration, during the medical examination (T-ME), and during radiographic procedure (T-XR)</time_frame>
    <description>Measure: Visual Analogue Scale (VAS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of children administered a rescue analgesic</measure>
    <time_frame>Within 60 minutes following administration of study medication</time_frame>
    <description>Measure: Clinical data (yes/no)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of children with adverse events in each group</measure>
    <time_frame>15 min (T-15), 30 min (T-30), 60 min (T-60), 90 min (T-90), 120 min (T-120) after medication administration, during the medical examination (T-ME), and during radiographic procedure (T-XR), 24 hours post-discharge from the ED</time_frame>
    <description>At each assessment points, the research nurse will record the occurence of adverse events (clinical data)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of children with an RSS score &gt; 3 in each group</measure>
    <time_frame>15 min (T-15), 30 min (T-30), 60 min (T-60), 90 min (T-90), 120 min (T-120) after medication administration, during the medical examination (T-ME), and during radiographic procedure (T-XR)</time_frame>
    <description>At each assessment points, the research nurse will evaluate the child's sedation level using the Ramsay Sedation Scale (RSS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction of children and parents regarding pain management</measure>
    <time_frame>120 min (T-120) after medication administration</time_frame>
    <description>Dichotomized question (yes/no)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of children with serious adverse events (SAE) in each group</measure>
    <time_frame>After medication administration until discharge</time_frame>
    <description>The research nurse will record the occurence of serious adverse events (clinical data)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Emergency Service, Hospital</condition>
  <condition>Child/Adolescent Problem</condition>
  <condition>Acute Pain</condition>
  <condition>Fentanyl</condition>
  <condition>Ibuprofen</condition>
  <condition>Analgesics, Opioid</condition>
  <condition>Anti-inflammatory Agents, Non-steroidal</condition>
  <arm_group>
    <arm_group_label>INF2.0 + IBU</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The participant will receive a dose of intranasal fentanyl (2.0 mcg/kg) AND a dose of oral ibuprofen (10 mg/kg).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>INF1.0 + IBU</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The participant will receive a dose of intranasal (1.0 mcg/kg) AND a dose of oral ibuprofen (10 mg/kg).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>INF2.0 + IBU</intervention_name>
    <description>Analgesics</description>
    <arm_group_label>INF2.0 + IBU</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>INF1.0 + IBU</intervention_name>
    <description>Analgesics</description>
    <arm_group_label>INF1.0 + IBU</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  pain score &gt;49 mm on the VAS at triage&#xD;
&#xD;
          -  between the ages of 7 and 17 years&#xD;
&#xD;
          -  presenting to the ED with a suspected fracture of the upper of lower limb&#xD;
&#xD;
          -  who can communicate in either French or English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  known allergy to fentanyl, ibuprofen&#xD;
&#xD;
          -  triage nurse suspicion of child abuse&#xD;
&#xD;
          -  inability to self-report pain&#xD;
&#xD;
          -  chronic pain that necessitates daily analgesic use&#xD;
&#xD;
          -  NSAID or opioid use within the three hours prior to ED presentation&#xD;
&#xD;
          -  trauma to &gt;1 limb&#xD;
&#xD;
          -  known hepatic or renal disease/dysfunction&#xD;
&#xD;
          -  known bleeding disorder&#xD;
&#xD;
          -  neuro-cognitive disability that precludes assent and/or participating in the study&#xD;
&#xD;
          -  known history of obstructive sleep apnea&#xD;
&#xD;
          -  a suspected fracture of the nose&#xD;
&#xD;
          -  significant head injury, as determined by the clinical team/triage nurse.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Le May Sylvie, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>St. Justine's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Stollery Children's Hospital</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Hospital London Health Sciences Centre</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Sainte-Justine Hospital</name>
      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>October 25, 2016</study_first_submitted>
  <study_first_submitted_qc>December 4, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 7, 2016</study_first_posted>
  <last_update_submitted>November 22, 2022</last_update_submitted>
  <last_update_submitted_qc>November 22, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 23, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>St. Justine's Hospital</investigator_affiliation>
    <investigator_full_name>Sylvie Le May</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Children</keyword>
  <keyword>Musculoskeletal injury</keyword>
  <keyword>Emergency department</keyword>
  <keyword>Analgesia</keyword>
  <keyword>Opioids</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Emergencies</mesh_term>
    <mesh_term>Acute Pain</mesh_term>
  </condition_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/NCT02985177
org study id: 99
nct id: NCT02985177
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
MSK-I is the most common cause for ED visits for children with pain, with a child's risk of
      sustaining a fracture ranging from 27-42% by the age of 16 years. MSK-I is known to generate
      moderate to severe pain in most children and the ED serves as the critical entry point for
      these injured children. This study aims to provide rapid and sustained pain management for
      children presenting with a MSK-I in the ED. The investigators will compare the efficacy of
      two possible medication combinations of fentanyl intranasal (1.0 mcg/kg) + oral ibuprofen (10
      mg/kg) and fentanyl intranasal (2.0 mcg/kg) + oral ibuprofen (10 mg/kg) for the rapid,
      adequate and sustained pain management of children with suspected fracture.

      The investigators believe that the combination of different dosage of intranasal fentanyl
      with ibuprofen will lead to better pain treatment by providing a consistent and adequate
      level of analgesia throughout the entire ED visit, including prior to physician exam and
      during painful radiologic procedures.
Pain management for children with a suspected fracture is suboptimal in the Emergency
      Department (ED). This type of musculoskeletal injury (MSK-I) often generates moderate to
      severe pain (> 49 mm on 0 to 100 mm Visual Analogue Scale (VAS)), and requires rapid and
      sustained pain management for the duration of the physical examination, diagnostic imaging
      (X-Ray), immobilization and occasionally fracture reduction. Current standard care includes
      the use of oral ibuprofen (IBU), a non-steroidal anti-inflammatory drug (NSAID), for
      mild-to-moderate MSK-I pain in the ED. However, ibuprofen has been shown to be inadequate for
      moderate-to-severe pain when used alone. A number of small/single centre studies suggest that
      intranasal fentanyl (INF) is effective for rapidly decreasing MSK-I related pain in children
      with a quick onset of 10 minutes and a peak action of 20 minutes. However, the duration of
      its analgesic effect is limited to a maximum of 60 minutes, which does not provide an optimal
      pain management for the duration of the ED stay, which typically lasts up to three hours.
      Typically, patients with a fracture have sustained pain throughout their ED stay due to
      imaging, splinting and repeated physical exams. Our objective is to examine the efficacy of a
      combination of intranasal and oral analgesics for pain management in children presenting to
      the ED with a suspected fracture. Our primary research question: For children presenting to
      the ED with a suspected fracture, is a combination of INF1.0 (1.0 mcg/kg, maximum dose of 100
      mcg) and IBU (10 mg/kg, maximum dose of 600 mg) more efficacious than a combination of INF2.0
      (2.0 mcg/kg, maximum dose of 100 mcg) and oral ibuprofen (10 mg/kg, maximum dose of 600 mg)
      to decrease pain at 15 minutes post-administration? Our primary hypothesis is: A combination
      of INF2.0 and IBU will be more efficacious than a combination of INF1.0 and IBU to decrease
      pain at 15 minutes post-administration.

      Methods. Design: This study is a single-blind, two-arm, three-centre RCT of a combination of
      analgesics for pain management of children presenting to the ED with a suspected fracture
      will be performed. Settings: Children will be recruited in the following EDs: CHU
      Sainte-Justine (Montreal, QC), Stollery Children's Hospital (Edmonton, AB), and Children's
      Hospital of the London Health Sciences Centre (London, ON). Sample. Inclusion criteria: Will
      be include children: (a) with a pain score >49 mm on VAS at triage, (b) between the ages of 7
      and 17 years, (c) presenting to the ED with a suspected fracture of the upper or lower limb,
      and (d) who can communicate in either French or English. Exclusion criteria: Will be exclude
      children with (a) known allergy to fentanyl or ibuprofen, (b) triage nurse suspicion of child
      abuse, (c) inability to self-report pain, (d) chronic pain that necessitates daily analgesic
      use, (e) NSAID or opioid analgesic use within the three hours prior to ED presentation, (f)
      trauma to >1 limb, (g) known hepatic or renal disease/dysfunction, (h) known bleeding
      disorder, (i) neuro-cognitive disability that precludes assent and/or participating in the
      study, (j) known history of obstructive sleep apnea (k) a suspected fracture of the nose, or
      (l) significant head injury, as determined by the clinical team/triage nurse.

      Allocation and Randomization: A biostatistician, independent to our study team, will generate
      the randomization scheme that will consist of a computer-generated random listing of the
      treatment using a 1:1 allocation scheme. Randomization will be stratified by center using
      block-randomization (with permuted block sizes). Enrolled children will be allocated to (a)
      INF 1.0 mcg/kg (up to a maximum of 100 mcg) via intranasal atomization + oral IBU 10 mg/kg
      (up to a maximum of 600 mg) OR (b) INF 2.0 mcg/kg (up to a maximum of 100 mcg) via intranasal
      atomization + oral IBU 10 mg/kg (up to a maximum of 600 mg.

      Sample Size: Accounting for a 10% attrition rate, we determined that enrollment of 172
      participants would provide at least 90 % power to detect a 10 mm absolute difference in mean
      pain scores between groups at 15 minutes post-medication administration (T-15), at an alpha
      level of 5 %.

      Primary efficacy outcome: Mean difference in pain scores between groups at 15 minutes
      post-medication administration (T-15) using the Visual Analogue Scale (VAS). Secondary
      outcomes: (a) Mean differences in pain scores between groups at 30 min (T-30), 60 min (T-60),
      90 min (T-90), 120 min (T-120) after medication administration, during the medical
      examination (T-ME), and during radiographic procedure (T-XR), (b) the proportion of children
      administered a rescue analgesic in the 60 minutes following administration of study
      medication, (c) the proportion of children with adverse events at T-15, T-30, T-60, T-90,
      T-120, T-ME and T-XR, (d) the proportion of children with serious adverse events at T-15,
      T-30, T-60, T-90, T-120, T-ME and T-XR, (e) the proportion of children in each group with an
      RSS score > 3 (f) satisfaction of children and parents regarding pain management (T-120).

      Relevance: In response to the persistent problem of inadequate and delayed analgesia, the
      investigators believe that a combination of rapidly acting (INF) and longer-acting (oral
      ibuprofen) medications will address both the delay in the time to effective analgesia and
      overall under-treatment of suspected fracture pain. The team anticipate that an RCT
      demonstrating the efficacy of a combination of fast and long-acting analgesics will
      significantly improve the treatment for children with a suspected fracture in the ED. The
      investigators hypothesize that use of INF2.0 and oral IBU will provide rapid pain relief that
      is sustained for the duration of the ED visit. Promotion of adequate acute pain treatment of
      children presenting to the ED will prevent the known short and long-term effects of
      inadequately treated pain in children previously demonstrated by our team, including
      unpleasant memories, stress and anxiety upon future visits to healthcare and compromised
      functional outcomes such as missed school.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Mean difference in pain scores between groups
time frame: 15 minutes post-medication administration (T-15)
description: Measure: Visual Analogue Scale (VAS)
measure: Mean difference in pain scores between groups
time frame: 30 min (T-30), 60 min (T-60), 90 min (T-90), 120 min (T-120) post-medication administration, during the medical examination (T-ME), and during radiographic procedure (T-XR)
description: Measure: Visual Analogue Scale (VAS)
measure: Proportion of children administered a rescue analgesic
time frame: Within 60 minutes following administration of study medication
description: Measure: Clinical data (yes/no)
measure: Proportion of children with adverse events in each group
time frame: 15 min (T-15), 30 min (T-30), 60 min (T-60), 90 min (T-90), 120 min (T-120) after medication administration, during the medical examination (T-ME), and during radiographic procedure (T-XR), 24 hours post-discharge from the ED
description: At each assessment points, the research nurse will record the occurence of adverse events (clinical data)
measure: Proportion of children with an RSS score > 3 in each group
time frame: 15 min (T-15), 30 min (T-30), 60 min (T-60), 90 min (T-90), 120 min (T-120) after medication administration, during the medical examination (T-ME), and during radiographic procedure (T-XR)
description: At each assessment points, the research nurse will evaluate the child's sedation level using the Ramsay Sedation Scale (RSS)
measure: Satisfaction of children and parents regarding pain management
time frame: 120 min (T-120) after medication administration
description: Dichotomized question (yes/no)
measure: Proportion of children with serious adverse events (SAE) in each group
time frame: After medication administration until discharge
description: The research nurse will record the occurence of serious adverse events (clinical data)
arm group label: INF2.0 + IBU
arm group type: Experimental
description: The participant will receive a dose of intranasal fentanyl (2.0 mcg/kg) AND a dose of oral ibuprofen (10 mg/kg).
arm group label: INF1.0 + IBU
arm group type: Active Comparator
description: The participant will receive a dose of intranasal (1.0 mcg/kg) AND a dose of oral ibuprofen (10 mg/kg).
intervention type: Drug
intervention name: INF2.0 + IBU
description: Analgesics
arm group label: INF2.0 + IBU
intervention type: Drug
intervention name: INF1.0 + IBU
description: Analgesics
arm group label: INF1.0 + IBU
criteria: 
gender: All
minimum age: 7 Years
maximum age: 17 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Le May Sylvie, PhD
role: Principal Investigator
affiliation: St. Justine's Hospital
facility: 
facility: 
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: St. Justine's Hospital
investigator full name: Sylvie Le May
investigator title: Principal Investigator
mesh term: Emergencies
mesh term: Acute Pain
sharing ipd: No