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RCT Evaluating Intranasal Fentanyl in the Pain Management of Children With Headaches

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ClinicalTrials.gov Identifier: NCT02638506
Recruitment Status : Not yet recruiting
First Posted : December 23, 2015
Last Update Posted : January 6, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

Background : Headaches are a common presentation for children consulting to the Emergency Department (ED). However, only few studies have evaluated the rapid pain improvement provided by medications in the acute management of headaches in the pediatric population.

Objective : To evaluate pain reduction provided by intranasal fentanyl (INF) compared to placebo in addition to ibuprofen for children presenting to a pediatric ED with moderate to severe headaches.

Methods : A single-center, double-blind, randomized, placebo controlled clinical trial will be conducted in an urban, university-affiliated, tertiary care pediatric hospital ED. All children eight to 18 years old who will present to the ED with headaches as a main chief complaint and with pain of ≥ 36 mm out of 100 on Visual Analog Scale (VAS) will be recruited. Study participants will be randomly allocated to receive INF 1.5 mcg/kg (maximum dose of 100 mcg) or similar volume of a placebo solution via an atomizer. Co-administration of oral ibuprofen 10 mg/kg (maximum dose of 600 mg) will also be provided to the two groups if not received in the previous 4 hours. The primary outcome will be the mean pain rating reduction at 15 minutes. The secondary outcomes will be mean pain reduction at 30 and 60 minutes, patient's and parental satisfaction levels, percent of being pain free, sedation score, immediate and within 72 hours adverse events, additional ED analgesics and other medications, length of ED stay, disposition outcomes, hospital admission rate and ED revisit rate within 72 hours. The primary analysis will use an intention-to-treat approach to compare mean pain score reduction between the two groups using a Student's T-test. The sample size of 60 participants per arm was calculated to have a power of 80% to identify a difference of 10 mm in the VAS.

Expected results : Our study might demonstrate that INF provides additional pain relief for children presenting to an ED with headaches. Providing INF could relieve their symptoms more quickly, potentially improve patient's and family's satisfaction, possibly reduce the length of their ED stay and consequently, have a significant impact on patient quality of care and cost-effectiveness.


Condition or disease Intervention/treatment Phase
Headaches Drug: Fentanyl Other: Salinex Phase 4

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial Evaluating the Additive Value of Intranasal Fentanyl on Ibuprofen in the Pain Management of Children With Moderate to Severe Headaches
Study Start Date : January 2016
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Intranasal Fentanyl
All patients will receive a 1.5 mcg⁄kg dose of fentanyl or an equivalent volume of similar looking placebo. This will be administered intranasally via a mucosal atomiser device (MAD) using 50 mcg/mL solution with a 2 mL syringe.
Drug: Fentanyl
All patients will receive a 1.5 mcg⁄kg dose of fentanyl. This will be administered intranasally via a mucosal atomiser device (MAD) using 50 mcg/mL solution with a 2 mL syringe
Other Name: Fentanyl citrate
Placebo Comparator: Salinex
All patients will receive a 1.5 mcg⁄kg dose of fentanyl or an equivalent volume of similar looking placebo. This will be administered intranasally via a mucosal atomiser device (MAD) using 50 mcg/mL solution with a 2 mL syringe.
Other: Salinex
All patients will receive an equivalent volume of similar looking placebo to fentanyl (1.5 mcg/kg dose). This will be administered intranasally via a mucosal atomiser device (MAD) using 50 mcg/mL solution with a 2 mL syringe


Outcome Measures

Primary Outcome Measures :
  1. The primary outcome measure will be the difference of the subjects' self-reported pain scores as assessed by the VAS at the fifteenth minute after administration of the initial drug therapy, which correspond to its peak analgesic effect. [ Time Frame: 15 minutes ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

- Inclusion criteria will consist of children aged eight to 18 years who present to the pediatric ED with a chief complaint of headaches, regardless of the type, with a moderate or severe pain score.

Pain was considered at least moderate if superior or equal to 36 mm on the VAS as demonstrated by Hirschfeld et. Al. This level have been chosen because it has been recognized that adequate sensitivity in analgesia trials for acute pain can only be obtained if patients experience at least moderate pain before administration of any treatment.

Exclusion Criteria:

  • 1. Allergy or any contra-indication to opioids and-or ibuprofen 2. Previous participation in study to preserve the statistic independence of each participant 3. Caregiver unable to provide consent (language barrier or lack of caregiver presence) 4. Circumstance which, in the opinion of the investigator, would adversely affect their participation in the trial such as a medical or psychiatric condition or a language barrier (neither French or English) 5. Nasopharyngeal anomalies, blockage or traumatized preventing nasal administration 6. Suspicion of life-threatening illness such as acute intracranial haemorrhage, meningitis, encephalopathy, or intracranial cerebral vascular occlusion 7. Signs of intracranial pressure or suspicion of intracerebral process such as mass or tumors (altered mental status, focal neurological deficit, etc.) 8. Any head injury with possible associate intracranial injury in the past 14 daysRecent or acute head injury 9. Current opioid use or opioid antagonist use 10. Intoxication
Contacts and Locations

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): NCT02638506


Contacts
Contact: Serge Gouin, MDCM, FRCPC 5149897290 sergegouin8@gmail.com
Contact: Serge Gouin 5149897290 sergegouin8@gmail.com

Locations
Canada, Quebec
CHU Ste-Justine
Montreal, Quebec, Canada, H3T1C5
Sponsors and Collaborators
St. Justine's Hospital
Investigators
Principal Investigator: Serge Gouin St. Justine's Hospital
More Information

Responsible Party: Serge Gouin, Associate Professor, St. Justine's Hospital
ClinicalTrials.gov Identifier: NCT02638506     History of Changes
Other Study ID Numbers: INF2016-1028
First Posted: December 23, 2015    Key Record Dates
Last Update Posted: January 6, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Serge Gouin, St. Justine's Hospital:
Headaches, Migraines, Fentanyl

Additional relevant MeSH terms:
Headache
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Pharmaceutical Solutions
Fentanyl
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics