RCT Evaluating Intranasal Fentanyl in the Pain Management of Children With Headaches
Status:
Terminated
Trial end date:
2020-08-18
Target enrollment:
Participant gender:
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.