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Non-Steroidal or Opioid Analgesia Use for Children With Musculoskeletal Injuries (No OUCH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03767933
Recruitment Status : Recruiting
First Posted : December 7, 2018
Last Update Posted : November 27, 2019
Sponsor:
Collaborators:
University of Manitoba
Centre hospitalier de l'Université de Montréal (CHUM)
University of Western Ontario, Canada
University of Calgary
The Hospital for Sick Children
University of Ottawa
Information provided by (Responsible Party):
University of Alberta

Brief Summary:

Musculoskeletal (MSK) injuries, including limb injuries, are the most common cause for Emergency Department (ED) visits for children with pain. Broken arms and legs are known to cause moderate to severe pain in most children, yet previous research shows that children's pain in the emergency department is still under-treated. Further, children are less likely to receive appropriate pain medicine than adults with similar injuries.

The purpose of this research study is to compare the effectiveness and safety of 3 different possible medication combinations, for the pain management of children with acute MSK limb injuries. The pain medicines the investigators are studying are ibuprofen (Advil/Motrin), acetaminophen (Tylenol/Tempra), and hydromorphone (Dilaudid).

This study will consist of 2 trials that will be run simultaneously. Eligible caregiver/ child pairs presenting to the emergency department with acute MSK limb injury will decide in which trial they wish to participate: the Opioid trial or the Non-Opioid trial. If they select the Non-opioid trial, they will have an equal chance of receiving either (a) Ibuprofen OR (b) Ibuprofen and acetaminophen. If they select the Opioid trial, they will have an equal chance of receiving either (a) Ibuprofen OR (b) Ibuprofen and acetaminophen OR (c) Ibuprofen and hydromorphone. Regardless of which study they choose, their child will, at minimum, receive Ibuprofen (Advil/Motrin) for their pain. All study medicines will be given in oral liquid form.

This study will help the investigators figure out which pain medicine or combination of pain medicines works best for children with limb injuries. Promotion of adequate acute pain treatment of children presenting to the ED may help prevent the known short and long-term effects of inadequately treated pain in children, including unpleasant memories, stress and anxiety upon future visits to healthcare, and compromised functional outcomes such as missed school.


Condition or disease Intervention/treatment Phase
Musculoskeletal Injury Drug: Ibuprofen Drug: Acetaminophen Drug: Hydromorphone Drug: Acetaminophen placebo Drug: Hydromorphone placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 536 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This study will be comprised of two Phase 2, six-centre, randomized, double blind, placebo-controlled trials that will be run simultaneously. The investigators expect that the number of participants recruited and the time to completion of both trials will be more efficient as recruitment for both will occur simultaneously. They propose to conduct this study with a novel preference-informed complementary trial design, in which they will conduct two simultaneous 'sister' trials. Caregiver/child pairs presenting to the ED with acute MSK limb injury will decide in which trial they wish to participate: the Opioid trial or the Non-Opioid trial. The design of each trial will be informed by its sister, or complementary, trial. Once the caregiver/child pair has chosen their preferred trial, conduct within each trial will follow traditional randomized, double-blind placebo-controlled superiority trial methodology. Study endpoints will be identical for both trials within this study.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Research staff, emergency department staff, and participants will be masked with respect to the allocated treatment. The data analyst will also be masked using codes that will not identify treatment groups until analysis is complete.
Primary Purpose: Treatment
Official Title: A Study of Non-Steroidal or Opioid Analgesia Use for Children With Musculoskeletal Injuries: The No OUCH Trials
Actual Study Start Date : April 20, 2019
Estimated Primary Completion Date : January 15, 2021
Estimated Study Completion Date : January 15, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Non-Opioid Trial: Arm 1
Oral ibuprofen (10mg/kg, max 600mg) + Oral acetaminophen placebo, both administered once during the study at the time of recruitment.
Drug: Ibuprofen
10mg/kg, maximum 600mg; Oral liquid
Other Names:
  • Advil
  • Motrin

Drug: Acetaminophen placebo
Oral liquid

Experimental: Non-Opioid Trial: Arm 2
Oral ibuprofen (10mg/kg, max 600mg) + Oral acetaminophen (15mg/kg, maximum 1000mg), both administered once during the study at the time of recruitment.
Drug: Ibuprofen
10mg/kg, maximum 600mg; Oral liquid
Other Names:
  • Advil
  • Motrin

Drug: Acetaminophen
15mg/kg, maximum 1000mg; Oral liquid
Other Names:
  • Tylenol
  • Tempra

Active Comparator: Opioid Trial: Arm 1
Oral ibuprofen (10mg/kg, max 600mg) + Oral acetaminophen placebo + Oral hydromorphone placebo, all administered once during the study at the time of recruitment.
Drug: Ibuprofen
10mg/kg, maximum 600mg; Oral liquid
Other Names:
  • Advil
  • Motrin

Drug: Acetaminophen placebo
Oral liquid

Drug: Hydromorphone placebo
Oral liquid

Experimental: Opioid Trial: Arm 2
Oral ibuprofen (10mg/kg, max 600mg) + Oral acetaminophen (15mg/kg, maximum 1000mg) + Oral hydromorphone placebo, all administered once during the study at the time of recruitment.
Drug: Ibuprofen
10mg/kg, maximum 600mg; Oral liquid
Other Names:
  • Advil
  • Motrin

Drug: Acetaminophen
15mg/kg, maximum 1000mg; Oral liquid
Other Names:
  • Tylenol
  • Tempra

Drug: Hydromorphone placebo
Oral liquid

Experimental: Opioid Trial: Arm 3
Oral ibuprofen (10mg/kg, max 600mg) + Oral acetaminophen placebo + Oral hydromorphone (0.05mg/kg, maximum 5 mg), all administered once during the study at the time of recruitment.
Drug: Ibuprofen
10mg/kg, maximum 600mg; Oral liquid
Other Names:
  • Advil
  • Motrin

Drug: Hydromorphone
0.05mg/kg, maximum 5 mg; Oral liquid
Other Names:
  • Dilaudid
  • pms-Hydromorphone

Drug: Acetaminophen placebo
Oral liquid




Primary Outcome Measures :
  1. vNRS Pain Score [ Time Frame: At 60 minutes post study drug administration (ie. T-60) ]
    The self-reported vNRS pain score. The 11 point 0-10 verbal Numerical Rating Scale (vNRS) is the most commonly used pain measurement tool for our study age group and has been validated in a number of children's pain studies.


Secondary Outcome Measures :
  1. Pain Score <3 [ Time Frame: At 60 minutes post study drug administration (ie. T-60) ]
    The proportion of patients with a vNRS pain score <3 at 60 minutes. The 11 point 0-10 verbal Numerical Rating Scale (vNRS) is the most commonly used pain measurement tool for our study age group and has been validated in a number of children's pain studies.

  2. Pain Score Reduction of at least 2 points out of 10 [ Time Frame: At 60 minutes post study drug administration (ie. T-60) ]
    The proportion of patients with a vNRS pain score reduction of at least 2 points out of 10. The 11 point 0-10 verbal Numerical Rating Scale (vNRS) is the most commonly used pain measurement tool for our study age group and has been validated in a number of children's pain studies.

  3. Between Group Pain Scores [ Time Frame: At 30, 60, 90, and 120 minutes post study drug administration, at Time of Medical Examination (approximately 90 minutes after time of recruitment) and at Time of X-Ray (approximately 60 minutes after time of recruitment) ]
    Between group differences in vNRS pain scores. The 11 point 0-10 verbal Numerical Rating Scale (vNRS) is the most commonly used pain measurement tool for our study age group and has been validated in a number of children's pain studies.

  4. Satisfaction with Pain Relief [ Time Frame: At the time of discharge from the emergency department (approximately 3 hours after time of recruitment) ]
    Self-reported caregiver and child satisfaction with pain relief and acceptability of study medications, using a previously employed 5 point Likert scale. This scale ranges from very satisfied to very dissatisfied for caregivers, and ranges from very happy to very sad for children.

  5. Length of Stay [ Time Frame: At the time of discharge from the emergency department (approximately 3 hours after time of recruitment) ]
    Emergency Department length of stay

  6. Missed Fractures or Dislocations [ Time Frame: In the 1 week following administration of study medication ]
    Frequency of missed fractures or dislocations

  7. Additional Analgesic Requirements [ Time Frame: In the 60 minutes following administration of study medication ]
    Proportion of children administered a rescue analgesic

  8. Time to Effective Analgesia [ Time Frame: At 30, 60, 90, and 120 minutes post study drug administration, and at the Time of Medical Examination (approximately 90 minutes after time of recruitment) and Time of X-Ray (approximately 60 minutes after time of recruitment) ]
    Time to effective analgesia, defined as the first vNRS pain score <3 post-intervention

  9. VAS Pain Scores [ Time Frame: At 30, 60, 90, and 120 minutes post study drug administration, and at the Time of Medical Examination (approximately 90 minutes after time of recruitment) and Time of X-Ray (approximately 60 minutes after time of recruitment) ]
    Children's self-reported pain intensity on the Visual Analog Scale (VAS). The VAS consists of a straight line with the anchor 'no pain' on one end and 'the worst imaginable pain' at the other end. It is a validated measure for the assessment of pain in children.

  10. FPS-R Pain Scores [ Time Frame: At 30, 60, 90, and 120 minutes post study drug administration, and at the Time of Medical Examination (approximately 90 minutes after time of recruitment) and Time of X-Ray (approximately 60 minutes after time of recruitment) ]
    Children's self-reported pain intensity on the Faces Pain Scale-Revised (FPS-R). The FPS-R consists of 6 faces, from left to right, each showing a greater level of pain than the previous one, with scores varying from 0 (no pain), 2, 4, 6, 8, and 10 (very much pain). The FPS-R is a validated measure for the assessment of pain in children.

  11. Adverse Events [ Time Frame: Up to 24 hours post study drug administration ]
    Proportion of children with adverse events related to study drug administration.

  12. Serious Adverse Events [ Time Frame: Up to 24 hours post study drug administration ]
    Proportion of children with any serious adverse events during the study period

  13. RSS [ Time Frame: At 0, 30, 60, 90, and 120 minutes post study drug administration, and at the Time of Medical Examination (approximately 90 minutes after time of recruitment) and Time of X-Ray (approximately 60 minutes after time of recruitment) ]
    Proportion of children in each study group with a Ramsay Sedation Score (RSS) score between 1 to 3

  14. Specific Adverse Events [ Time Frame: Up to 24 hours post study drug administration ]
    Proportion of children with each specific adverse event type during the study period



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Child aged 6-17 years
  2. Presenting to the emergency department with an acute limb injury (<24 hours old) that is neither obviously deformed nor having neuro-vascular compromise (as assessed by the triage nurse)
  3. Self-reported pain score > 5 on the 0 to 10 verbal Numerical Rating Scale at triage

Exclusion Criteria:

  1. Deemed to require immediate intravenous (IV) or intranasal (IN) pain medications by the clinical team
  2. Previously known hypersensitivity to study medications
  3. Acetaminophen or NSAID use within 3 hours prior to recruitment
  4. Opioid use within 1 hour prior to recruitment
  5. Caregiver and/or child cognitive impairment precluding the ability to self-report pain or respond to study questions
  6. Injury suspected to be due to non-accidental trauma/ child abuse (as assessed by the triage nurse or reported by the family)
  7. Suspected multi-limb fracture
  8. Chronic pain that necessitates daily analgesic use
  9. Hepatic or renal disease/dysfunction
  10. Bleeding disorder
  11. Known pregnancy
  12. Vomiting that precludes the ability to take oral medications (as determined by the family)
  13. Caregiver and/or child inability to communicate fluently in English or French in the absence of a native language interpreter
  14. Caregiver unavailable for follow-up
  15. Previous enrolment in the NO OUCH study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03767933


Contacts
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Contact: Manasi Rajagopal 780-248-5440 manasi@ualberta.ca
Contact: Samina Ali, MD 780-248-5575 sali@ualberta.ca

Locations
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Canada, Alberta
Alberta Children's Hospital Recruiting
Calgary, Alberta, Canada, T3B 6A9
Contact: Antonia Stang, MD MBA MSc    403 955 7493    Antonia.Stang@ahs.ca   
Principal Investigator: Antonia Stang, MD MBA MSc         
Stollery Children's Hospital Emergency Department Recruiting
Edmonton, Alberta, Canada, T6G 2B7
Contact: Manasi Rajagopal    780-248-5440    manasi@ualberta.ca   
Canada, Manitoba
Children's Hospital of Winnipeg Recruiting
Winnipeg, Manitoba, Canada, R3A 1S1
Contact: Scott Sawyer, MD    204 787 2433    SSawyer@exchange.hsc.mb.ca   
Principal Investigator: Scott Sawyer, MD         
Canada, Ontario
Childrens Hospital at London Health Sciences Recruiting
London, Ontario, Canada, N6A 5W9
Contact: Naveen Poonai, MSc, MD    519 694 5309    Naveen.Poonai@lhsc.on.ca   
Principal Investigator: Naveen Poonai, MD         
Children's Hospital of Eastern Ontario Recruiting
Ottawa, Ontario, Canada, K1H 8L1
Contact: Maala Bhatt, MD, MSc.    613 737 7600 ext 3364    mbhatt@cheo.on.ca   
Principal Investigator: Maala Bhatt, MD, MSc.         
Canada, Quebec
CHU Sainte-Justine Recruiting
Montréal, Quebec, Canada, HT3 1C5
Contact: Serge Gouin, MD    514 345 4931 ext 3498    sergegouin8@gmail.com   
Principal Investigator: Serge Gouin, MD         
Sponsors and Collaborators
University of Alberta
University of Manitoba
Centre hospitalier de l'Université de Montréal (CHUM)
University of Western Ontario, Canada
University of Calgary
The Hospital for Sick Children
University of Ottawa
Investigators
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Principal Investigator: Samina Ali, MD University of Alberta/Stollery Children's Hospital

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Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT03767933    
Other Study ID Numbers: Pro00073476
First Posted: December 7, 2018    Key Record Dates
Last Update Posted: November 27, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

This study will comply with the CIHR Open Access Policy. The trials will be registered at ClinicalTrials.gov, and results information from this study will be submitted to ClinicalTrials.gov. Also, every attempt will be made to publish results in peer-reviewed journals. Data from this study may be requested from other researchers 2 years after the completion of the primary endpoint by contacting the Women and Children's Health Research Institute (WCHRI) Data Coordinating Center (DCC). Conduct, reporting, editing, and publication of resultant scholarly work will be guided by the International Committee of Journal Medical Editors (ICJME)'s published recommendations.

The identity of participants will not be revealed in any published data or in presentation of the information obtained as a result of this study.

Time Frame: Data from this study may be requested from other researchers 2 years after the completion of the primary endpoint
Access Criteria: Researchers will need to contact the WCHRI DCC for access to the data

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by University of Alberta:
Pediatrics
Emergency
Analgesia
Opioids
Combination therapy
Ibuprofen
Acetaminophen
Hydromorphone
Additional relevant MeSH terms:
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Wounds and Injuries
Acetaminophen
Ibuprofen
Analgesics, Opioid
Hydromorphone
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Non-Narcotic
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action