Pediatrics/original researchA Randomized Controlled Trial Comparing Intranasal Fentanyl to Intravenous Morphine for Managing Acute Pain in Children in the Emergency Department
Introduction
In the pediatric emergency department (ED), rapid, effective, and painless delivery of analgesia is desired.1, 2 As a consequence, it is routine in many facilities to give intravenous (IV) morphine to children presenting to the ED in moderate to severe pain.3, 4 However, the insertion of an IV cannula can, at times, require special skills, is time and staff dependent, and is painful and anxiety provoking for some children. Alternative methods of providing safe and effective analgesia include the intranasal route for the administration of opiates such as fentanyl and diamorphine.5, 6, 7, 8, 9 A study in a tertiary pediatric ED illustrated the safety and efficacy of intranasal fentanyl in a pediatric population.8 Two other ED studies have compared an intranasal opiate with intramuscular morphine as their criterion standard.5, 6
There has not been a study comparing an intranasal opiate with a drug with a similar onset of action. Intramuscular morphine would be expected to take up to 30 minutes to achieve adequate analgesia, whereas intranasal formulations take 5 to 10 minutes. In addition, if it were possible to provide adequate analgesia without IV access, then the administration of analgesia would be hastened, which would equate to greater patient comfort and satisfaction.
Our objective was to illustrate the comparative effectiveness of intranasal fentanyl to IV morphine in the pediatric ED. The primary endpoint was to demonstrate equivalence in pain control.
Section snippets
Study Design and Setting
This study was a double-blind, placebo-controlled, randomized trial within a tertiary pediatric ED with an annual census of 42,000 attendances. Enrollments were made from September 2001 to January 2005.
Selection of Participants
A convenience sample of children aged 7 to 15 years, presenting with clinically deformed closed long-bone fractures, was identified at triage and invited to join the study. Verbal consent was obtained from both the accompanying parent and the child, when appropriate. Written consent was not
Results
We enrolled 67 children between September 2001 and January 2005 (Figure 2). Baseline characteristics were similar between groups (Table 2).
The visual analog scale scores during the 5 periods at which pain was assessed and between intranasal fentanyl and IV morphine are illustrated in Figure 3. Overall, no statistically significant differences in visual analog scale scores between the 2 treatment arms either preanalgesia or at 5, 10, 20, or 30 minutes postanalgesia were observed (P=.333).
Limitations
We used the visual analog scale as our pain measurement tool because it has been validated in recent studies.11 In the clinical setting, it is a somewhat cumbersome tool, requiring a 100-mm diagram and the child to mark his or her pain level. Children older than 6 years were included to avoid difficulty with understanding a pain measurement tool in the acute setting without previous education.13, 14 The verbal 0-to-10 scale (numeric rating scale) has been less validated in the pediatric
Discussion
Intranasal drug administration has been studied widely in postoperative patients16, 17, 18 and burn patients.19, 20, 21 To our knowledge, this study is the first to compare directly intranasal fentanyl with IV morphine in a pediatric population. We were able to demonstrate equivalence in pain scores at all intervals during the study. The combined visual analog scale score showed significant reduction at all intervals postanalgesia except at 30 minutes, which reflects reduction in pain for both
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Supervising editor: Steven M. Green, MD
Author contributions: MB conceived, designed, and conducted the study and undertook article writing and acts as guarantor. IJ assisted in planning and manuscript revision and undertook statistical analysis. BK conducted patient enrollments and article revision. DO'B was involved in planning, obtaining funding, and article revision.
Reprints not available from the authors.
Funding and support: Funded by an ACEM Morson Taylor Research Grant.