Intranasal Fentanyl for Initial Treatment of a Vaso-occlusive Crisis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Daniel Marc Fein, Montefiore Medical Center
ClinicalTrials.gov Identifier:
NCT01482091
First received: November 22, 2011
Last updated: July 11, 2016
Last verified: July 2016

November 22, 2011
July 11, 2016
December 2011
February 2015   (final data collection date for primary outcome measure)
Change in Pain Score 20 Minutes After Administration of Study Drug [ Time Frame: Baseline and 20 minutes after administration of study drug ] [ Designated as safety issue: No ]

Change in pain score between 0 and 20 minutes using the Wong Baker FACES pain scale (WBFPS). The WBFPRS has six faces, with each face representing an increasing severity of pain the more rightward it is on the scale (0 is the lowest score , which represents the least amount of pain, while 10 is the highest score which represents the greatest level of pain).. Each face has an even number underneath it, consecutively.

To calculate the change, the reported pain score at 20 minutes was subtracted from the reported baseline pain score. Thus, the higher change in pain score is indicative of a GREATER change in pain (i.e. greater decrease in pain at 20 minutes compared to baseline). The greatest possible changes in pain would be a 10 (pain score of 10 at baseline and 0 at 20 minutes) representing a DECREASE in pain between the two time points, and -10 (pain score of 0 at baseline and 10 at 20 minutes) representing a INCREASE in pain between the two time points.

Change in Pain Score 20 Minutes After Administration of Study Drug [ Time Frame: Baseline and 20 minutes after administration of study drug ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01482091 on ClinicalTrials.gov Archive Site
  • Presence of Bradycardia [ Time Frame: Every 5 minutes until 30 minutes after study drug administration ] [ Designated as safety issue: Yes ]
    Number of participants who had bradycardia
  • Presence of Headache [ Time Frame: Participants will be followed for the duration of their ED visit, an expected average of 6 hours ] [ Designated as safety issue: Yes ]
  • Admission Rate [ Time Frame: This will be assessed at either discharge from the ED or admission to an inpatient unit, an expected average of 6 hours after triage ] [ Designated as safety issue: No ]
  • Length of Stay in ED [ Time Frame: Time from triage until either discharge from the ED or admission to an inpatient unit, an expected average of 6 hours ] [ Designated as safety issue: No ]
    Given multiple confounding factors, reliable data was not able to be obtained for this outcome measure
  • Total Amount of Narcotics Administered [ Time Frame: Participants will be followed for the duration of their ED visit, an expected average of 6 hours ] [ Designated as safety issue: No ]
    Given multiple confounding and extraneous factors, reliable data was not able to be obtained for this outcome measure
  • Time to Study Drug Administration [ Time Frame: Time from triage to adminstration of study drug ] [ Designated as safety issue: No ]
  • Change in Pain Score at 10 Minutes [ Time Frame: Baseline and 10 minutes after administration of study drug ] [ Designated as safety issue: No ]

    Change in pain score between 0 and 10 minutes using the Wong Baker FACES pain scale (WBFPS). The WBFPRS has six faces, with each face representing an increasing severity of pain the more rightward it is on the scale (0 is the lowest score , which represents the least amount of pain, while 10 is the highest score which represents the greatest level of pain).. Each face has an even number underneath it, consecutively.

    To calculate the change, the reported pain score at 10 minutes was subtracted from the reported baseline pain score. Thus, the higher change in pain score is indicative of a GREATER change in pain (i.e. greater decrease in pain at 10 minutes compared to baseline). The greatest possible changes in pain would be a 10 (pain score of 10 at baseline and 0 at 10 minutes) representing a DECREASE in pain between the two time points, and -10 (pain score of 0 at baseline and 10 at 10 minutes) representing a INCREASE in pain between the two time points.

  • Change in Pain Score at 30 Minutes [ Time Frame: Baseline and 30 minutes after administration of study drug ] [ Designated as safety issue: No ]

    Change in pain score between 0 and 30 minutes using the Wong Baker FACES pain scale (WBFPS). The WBFPRS has six faces, with each face representing an increasing severity of pain the more rightward it is on the scale (0 is the lowest score, which represents the least amount of pain, while 10 is the highest score which represents the greatest level of pain).. Each face has an even number underneath it, consecutively.

    To calculate the change, the reported pain score at 30 minutes was subtracted from the reported baseline pain score. Thus, the higher change in pain score is indicative of a GREATER change in pain (i.e. greater decrease in pain at 30 minutes compared to baseline). The greatest possible changes in pain would be a 10 (pain score of 10 at baseline and 0 at 30 minutes) representing a DECREASE in pain between the two time points, and -10 (pain score of 0 at baseline and 10 at 30 minutes) representing a INCREASE in pain between the two time points.

  • Change in Pain Score [ Time Frame: Baseline and immediately prior to IV insertion ] [ Designated as safety issue: No ]
    Due to confounding factors we were unable to obtain reliable data for this outcome
  • Respiratory Distress [ Time Frame: Every 5 minutes until 30 minutes after study drug administration ] [ Designated as safety issue: Yes ]
    Participants who had respiratory distress within 30 min of study drug administration
  • Hypotension [ Time Frame: Every 5 minutes until 30 minutes after study drug administration ] [ Designated as safety issue: Yes ]
    Participants who had hypotension within 30 min of study drug administration
  • Hypoxia [ Time Frame: Every 5 minutes until 30 minutes after study drug administration ] [ Designated as safety issue: Yes ]
    Number of participants who had hypoxia within 30 min of study drug adminsitration
  • Heart rate prior to and after the administration of study drug [ Time Frame: Every 5 minutes until 30 minutes after study drug administration ] [ Designated as safety issue: Yes ]
  • Presence of nausea, vomiting, itching and headache [ Time Frame: Participants will be followed for the duration of their ED visit, an expected average of 6 hours ] [ Designated as safety issue: Yes ]
  • Admission Rate [ Time Frame: This will be assessed at either discharge from the ED or admission to an inpatient unit, an expected average of 6 hours after triage ] [ Designated as safety issue: No ]
  • Length of Stay in ED [ Time Frame: Time from triage until either discharge from the ED or admission to an inpatient unit, an expected average of 6 hours ] [ Designated as safety issue: No ]
  • Total Amount of Narcotics Administered [ Time Frame: Participants will be followed for the duration of their ED visit, an expected average of 6 hours ] [ Designated as safety issue: No ]
  • Time to Study Drug Administration [ Time Frame: Time from triage to adminstration of study drug, an expected average of 20 minutes ] [ Designated as safety issue: No ]
  • Change in Pain Score [ Time Frame: Baseline and 10 minutes after administration of study drug ] [ Designated as safety issue: No ]
  • Change in Pain Score [ Time Frame: Baseline and 30 minutes after administration of study drug ] [ Designated as safety issue: No ]
  • Change in Pain Score [ Time Frame: Baseline and immediately prior to IV insertion ] [ Designated as safety issue: No ]
  • Respiratory rate prior to and after the administration of study drug [ Time Frame: Every 5 minutes until 30 minutes after study drug administration ] [ Designated as safety issue: Yes ]
  • Blood Pressure prior to and after the administration of study drug [ Time Frame: Every 5 minutes until 30 minutes after study drug administration ] [ Designated as safety issue: Yes ]
  • Oxygen saturation prior to and after the administration of study drug [ Time Frame: Every 5 minutes until 30 minutes after study drug administration ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Intranasal Fentanyl for Initial Treatment of a Vaso-occlusive Crisis
Intranasal Fentanyl for Initial Treatment of a Vaso-occlusive Crisis: A Randomized, Double Blind Placebo Controlled Trial
The purpose of this study is to determine if intranasal fentanyl can decrease the pain of patients with sickle cell disease who present to the pediatric emergency department with a vaso-occlusive crisis.

Principles of therapy for treatment of vaso-occlusive crises include early aggressive analgesic therapy with opiates and non-steroidal anti-inflammatory agents as well as fluid administration. It is known that there is a significant delay in time to administration of analgesics in children with VOC in the ED. The most easily modifiable factor that contributes to delayed opiate administration is route of administration.

Intranasal medication administration is an easy, rapid way to administer opiates with minimal discomfort as well as bypassing first past metabolism and the blood brain barrier. Intranasal fentanyl has been shown to be a safe and effective analgesic for treatment of acute pain in children, reaching therapeutic effect in 2-10 minutes after administration.

The investigators believe that intranasal fentanyl therapy will be able to provide expedited and effective pain therapy to patients with sickle cell disease presenting to the pediatric emergency department with a vaso-occlusive crisis

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Anemia, Sickle Cell
  • Pain
  • Drug: Fentanyl Citrate
    A single dose of fentanyl citrate (2 mcg/kg; max 100mcg) administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device
  • Drug: Normal Saline
    A single dose of equivalent volume of 0.9% Normal Saline will be administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device.
  • Placebo Comparator: Intranasal Saline
    Intervention: Drug: Normal Saline
  • Experimental: Intranasal Fentnayl
    Intervention: Drug: Fentanyl Citrate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
124
Not Provided
February 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Sickle Cell Disease
  • Ages 3 years - 21 years

Exclusion Criteria for Enrollment:

  • Pregnancy
  • Known allergy to Fentanyl
  • Usage of daily home opiates

Exclusion Criteria at presentation in ED with a painful crisis:

  • Wong Baker FACES Pain Score <6
  • Systolic blood pressure < 5 percentile for age
  • Oxygen saturation <92% on room air
  • Temperature > 102°F
  • Respiratory distress
  • Priapism
  • Isolated abdominal pain
  • Isolated headache
  • New neurological symptoms
  • Severe rhinorrhea or epistaxis
  • History of trauma
  • Pregnancy
Both
3 Years to 21 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01482091
11-09-343
Yes
Not Provided
Not Provided
Daniel Marc Fein, Montefiore Medical Center
Montefiore Medical Center
Not Provided
Principal Investigator: Daniel M Fein, MD Children's Hospital at Montefiore
Study Director: Daniel M Fein, MD Children's Hospital at Montefiore
Montefiore Medical Center
July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP