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

NCT02985177 | Withdrawn Phase 4 DMC

• 1 other identifier: 99
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 3

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 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.

Conditions

Emergency Service, Hospital; Child/Adolescent Problem; Acute Pain; Fentanyl; Ibuprofen; Analgesics, Opioid; Anti-inflammatory Agents, Non-steroidal

Keywords

Children; Musculoskeletal injury; Emergency department; Analgesia; Opioids

Outcome Measures

Primary Outcomes (1)

• Mean difference in pain scores between groups

  Measure: Visual Analogue Scale (VAS)

  15 minutes post-medication administration (T-15)

Secondary Outcomes (6)

• Mean difference in pain scores between groups

  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)

• Proportion of children administered a rescue analgesic

  Within 60 minutes following administration of study medication

• Proportion of children with adverse events in each group

  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

• Proportion of children with an RSS score > 3 in each group

  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)

• Satisfaction of children and parents regarding pain management

  120 min (T-120) after medication administration

Study Arms (2)

INF2.0 + IBU

EXPERIMENTAL

The participant will receive a dose of intranasal fentanyl (2.0 mcg/kg) AND a dose of oral ibuprofen (10 mg/kg).

Drug: INF2.0 + IBU

INF1.0 + IBU

ACTIVE COMPARATOR

The participant will receive a dose of intranasal (1.0 mcg/kg) AND a dose of oral ibuprofen (10 mg/kg).

Drug: INF1.0 + IBU

Interventions

INF2.0 + IBU DRUG

Analgesics

INF2.0 + IBU

INF1.0 + IBU DRUG

Analgesics

INF1.0 + IBU

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• pain score \>49 mm on the VAS at triage
• between the ages of 7 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

You may not qualify if:

• known allergy to fentanyl, ibuprofen
• 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.

Sponsors & Collaborators

• St. Justine's Hospital: lead

Study Sites (3)

Stollery Children's Hospital

Edmonton, Alberta, Canada

Location

Children's Hospital London Health Sciences Centre

London, Ontario, Canada

Location

CHU Sainte-Justine Hospital

Montreal, Quebec, Canada

Location

MeSH Terms

Conditions

Emergencies; Acute Pain; Agnosia

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Le May Sylvie, PhD

  St. Justine's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 25, 2016
• First Posted: December 7, 2016
• Study Start: January 1, 2020
• Primary Completion: July 1, 2021
• Study Completion: September 1, 2021
• Last Updated: November 23, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)