Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A RCT of a Combination of Analgesics for Pain Management in Children With a Suspected Fracture (CAST)

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: NCT02985177
Recruitment Status : Not yet recruiting
First Posted : December 7, 2016
Last Update Posted : September 20, 2018
Sponsor:
Information provided by (Responsible Party):
Sylvie Le May, St. Justine's Hospital

Brief Summary:

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 2 possible medication combinations (fentanyl intranasal + oral hydromorphone or fentanyl intranasal + oral ibuprofen) for the rapid, adequate and sustained pain management of children with suspected fracture.

The investigators believe that the addition of HM to INF 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.


Condition or disease Intervention/treatment Phase
Emergency Service, Hospital Child/Adolescent Problem Acute Pain Fentanyl Ibuprofen Analgesics, Opioid Anti-inflammatory Agents, Non-steroidal Drug: Fentanyl intranasal + Oral Hydromorphone Drug: Fentanyl intranasal + Oral ibuprofen Phase 4

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of a Combination of Analgesics for Pain Management in Children With a Suspected Fracture at Triage (CAST Trial)
Estimated Study Start Date : December 2019
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: INF + HM
The participant will receive a dose of intranasal fentanyl (1.5 mcg/kg up to a maximum of 100 mcg) AND a dose of oral hydromorphone (0.04mg/kg up to a maximum of 2 mg).
Drug: Fentanyl intranasal + Oral Hydromorphone
Analgesics

Active Comparator: INF + IBU
The participant will receive a dose of intranasal (1.5 mcg/kg up to a maximum of 100 mcg) AND a dose of oral ibuprofen (10 mg/kg up to a maximum of 600 mg)
Drug: Fentanyl intranasal + Oral ibuprofen
Analgesics




Primary Outcome Measures :
  1. Proportion of children in each group with a pain intensity score <30 mm at 60 minutes post-medication administration [ Time Frame: 60 minutes post-medication administration (T-60) ]
    Measure: Visual Analogue Scale (VAS)


Secondary Outcome Measures :
  1. Mean pain scores [ Time Frame: Time of the administration of medication (T-0), 10 min (T-10), 20 min (T-20), 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) ]
    Measure: Visual Analogue Scale (VAS)

  2. Proportion of children administered a rescue analgesic [ Time Frame: Within 60 minutes following administration of study medication ]
  3. Proportion of children with side effects [ Time Frame: 10 min (T-10), 20 min (T-20), 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 ]
    At each assessment points, the research nurse will evaluate the presence of side effects (clinical data)

  4. Proportion of children in each group with an RSS score between 1 to 3 [ Time Frame: 10 min (T-10), 20 min (T-20), 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) ]
    At each assessment points, the research nurse will evaluate the child's sedation level using the Ramsay Sedation Scale (RSS)

  5. Parental and child reports of acceptability of the medication [ Time Frame: 120 min (T-120) after medication administration ]
    Dichotomized question (yes/no) on the acceptability of the medication

  6. Self-reported levels of satisfaction of children and parents with pain management [ Time Frame: 120 min (T-120) after medication administration ]
    Dichotomized question (yes/no) on the levels of satisfaction of children and parents with pain management

  7. Mean differences in pain scores (between groups) [ Time Frame: Time of the administration of medication (T-0), 10 min (T-10), 20 min (T-20), 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) ]
    Measure: Visual Analogue Scale (VAS)

  8. Occurence of Serious adverse events [ Time Frame: 10min (T-10), 20 min (T-20), 30 min (T-30), 60 min (T-60), 90 min (T-90), 120 min (T-120) after medication administration, during medical examination (T-ME) and during radiographic procedure (T-XR) ]
    Checklist of Serious Adverse events



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.


Layout table for eligibility information
Ages Eligible for Study:   8 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • pain score >49 mm on the VAS at triage
  • between the ages of 8 and 17 years
  • presenting to the ED with a suspected fracture of the upper of lower limb
  • who can communicate in either French or English

Exclusion Criteria:

  • known allergy to fentanyl, hydromorphone, ibuprofen, or artificial colouring
  • triage nurse suspicion of child abuse
  • inability to self-report pain
  • chronic pain that necessitates daily analgesic use
  • NSAID or opioid use within the three hours prior to ED presentation
  • trauma to >1 limb
  • known hepatic or renal disease/dysfunction
  • known bleeding disorder
  • neuro-cognitive disability that precludes assent and/or participating in the study
  • known history of obstructive sleep apnea
  • a suspected fracture of the nose
  • significant head injury, as determined by the clinical team/triage nurse.

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): NCT02985177


Contacts
Layout table for location contacts
Contact: Sylvie Le May, PhD 514-345-4931 ext 4938 sylvie.lemay@umontreal.ca
Contact: Serge Gouin, MD, FRCPC 514-345-4931 ext 3640

Sponsors and Collaborators
St. Justine's Hospital
Investigators
Layout table for investigator information
Principal Investigator: Le May Sylvie, PhD St. Justine's Hospital

Layout table for additonal information
Responsible Party: Sylvie Le May, Principal Investigator, St. Justine's Hospital
ClinicalTrials.gov Identifier: NCT02985177     History of Changes
Other Study ID Numbers: 99
First Posted: December 7, 2016    Key Record Dates
Last Update Posted: September 20, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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 Sylvie Le May, St. Justine's Hospital:
Children
Musculoskeletal injury
Emergency department
Analgesia
Opioids
Additional relevant MeSH terms:
Layout table for MeSH terms
Emergencies
Acute Pain
Disease Attributes
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Ibuprofen
Fentanyl
Hydromorphone
Analgesics
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action