Nebulized Fentanyl study: Data Sheet, Study Flow, Data Collection Tips, FAQs
 

Overview: This study seeks to determine if children being treated for painful conditions receive adequate analgesia from fentanyl citrate administered either nebulized or intravenously.

Primary Endpoints: 1. Child pain as assessed by VAS or Cheops

Eligible Patients: Children between 2 years and less than 18 years old who were going to receive IV pain medications who did not otherwise need an IV at the time of the study.  Patients who are pregnant or nursing, are intoxicated, have an allergy to fentanyl, or have a history of kidney or liver disease are ineligible.
 

Study Design: Prospective, randomized clinical trial.
 

Anticipated Benefits: Child may receive pain relief during participation in study.  Children randomized to nebulized group may receive relief without IV placement.
 

Potential Risks: Risks associated narcotic medications, potential for respiratory depression.
 

Research Associate’s Role:  Research Associates are responsible for identifying eligible patients for this study and recruiting them.  Review the exclusion criteria detailed in the study packet with the patient’s physician prior to enrollment.
 

Physician’s Role: Physicians will complete a 100 mm VAS at each time point representing their perception of the patient’s pain.  Physicians will also assign CHEOPS scores to the patient if the RA is untrained in assigning such scores.
 

Location of Study Packets: Team Center C