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Completed

NCT Number: NCT01482091

Intranasal Fentanyl for Initial Treatment of a Vaso-occlusive Crisis

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.

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Key information

Conditions

Anemia, Sickle Cell Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Vaso-Occlusive Crises

Age range

3 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Children's Hospital at Montefiore

The Bronx, New York, 10467, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fentanyl Citrate

Drug

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

normal saline

Drug

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.

Primary outcomes

  1. Change in Pain Score 20 Minutes After Administration of Study Drug

    Time frame: Baseline and 20 minutes after administration of study drug

    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.

Secondary outcomes

  1. Presence of Bradycardia

    Time frame: Every 5 minutes until 30 minutes after study drug administration

    Number of participants who had bradycardia

  2. Presence of Headache

    Time frame: Participants will be followed for the duration of their ED visit, an expected average of 6 hours

  3. 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

  4. 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

    Given multiple confounding factors, reliable data was not able to be obtained for this outcome measure

  5. Total Amount of Narcotics Administered

    Time frame: Participants will be followed for the duration of their ED visit, an expected average of 6 hours

    Given multiple confounding and extraneous factors, reliable data was not able to be obtained for this outcome measure

  6. Time to Study Drug Administration

    Time frame: Time from triage to adminstration of study drug

  7. Change in Pain Score at 10 Minutes

    Time frame: Baseline and 10 minutes after administration of study drug

    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.

  8. Change in Pain Score at 30 Minutes

    Time frame: Baseline and 30 minutes after administration of study drug

    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.

  9. Change in Pain Score

    Time frame: Baseline and immediately prior to IV insertion

    Due to confounding factors we were unable to obtain reliable data for this outcome

  10. Respiratory Distress

    Time frame: Every 5 minutes until 30 minutes after study drug administration

    Participants who had respiratory distress within 30 min of study drug administration

  11. Hypotension

    Time frame: Every 5 minutes until 30 minutes after study drug administration

    Participants who had hypotension within 30 min of study drug administration

  12. Hypoxia

    Time frame: Every 5 minutes until 30 minutes after study drug administration

    Number of participants who had hypoxia within 30 min of study drug adminsitration

Sponsors and collaborators

Lead sponsor

Montefiore Medical Center

Other

Registry information

Official study title

Intranasal Fentanyl for Initial Treatment of a Vaso-occlusive Crisis: A Randomized, Double Blind Placebo Controlled Trial

Important dates

Study start
2011
Primary completion
2015
First posted
Nov 30, 2011
Registry last updated
Aug 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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