Study protocol of a randomised controlled trial of intranasal ketamine compared with intranasal fentanyl for analgesia in children with suspected, isolated extremity fractures in the paediatric emergency department.
Fentanyl is the most widely studied intranasal (IN) analgesic in children. IN subdissociative (INSD) ketamine may offer a safe and efficacious alternative to IN fentanyl and may decrease overall opioid use during the emergency department (ED) stay. This study examines the feasibility of a larger, multicentre clinical trial comparing the safety and efficacy of INSD ketamine to IN fentanyl and the potential role for INSD ketamine in reducing total opioid medication usage.



This double-blind, randomised controlled, pilot trial will compare INSD ketamine (1 mg/kg) to IN fentanyl (1.5 μg/kg) for analgesia in 80 children aged 4-17 years with acute pain from a suspected, single extremity fracture. The primary safety outcome for this pilot trial will be the frequency of cumulative side effects and adverse events at 60 min after drug administration. The primary efficacy outcome will be exploratory and will be the mean reduction of pain scale scores at 20 min. The study is not powered to examine efficacy. Secondary outcome measures will include the total dose of opioid pain medication in morphine equivalents/kg/hour (excluding study drug) required during the ED stay, number and reason for screen failures, time to consent, and the number and type of protocol deviations. Patients may receive up to 2 doses of study drug.



This study was approved by the US Food and Drug Administration, the local institutional review board and the study data safety monitoring board. This study data will be submitted for publication regardless of results and will be used to establish feasibility for a multicentre, non-inferiority trial.



NCT02521415.
Division of Pediatric Emergency Medicine, Department of Emergency Medicine, Carolinas Medical Center, Charlotte, North Carolina, USA.
Stacy L
SL
Reynolds
Mecklenberg EMS Agency (Medic), Charlotte, North Carolina, USA.
Jonathan R
JR
Studnek
Department of Emergency Medicine, Carolinas Medical Center, Charlotte, North Carolina, USA.
Kathleen
K
Bryant
Department of Orthopedics, Carolinas Medical Center, Charlotte, North Carolina, USA.
Kelly
K
VanderHave
Department of Pediatric Surgery, Levine Children's Hospital, Concord, North Carolina, USA.
Eric
E
Grossman
Dickson Advanced Analytics, Carolinas Healthcare System, Charlotte, North Carolina, USA.
Charity G
CG
Moore
Department of Emergency Medicine, Carolinas Medical Center, Charlotte, North Carolina, USA.
James
J
Young
Department of Emergency Medicine, Carolinas Medical Center, Charlotte, North Carolina, USA.
Melanie
M
Hogg
Department of Emergency Medicine, Carolinas Medical Center, Charlotte, North Carolina, USA.
Michael S
MS
Runyon
D000281:Administration, Intranasal; D000293:Adolescent; D000698:Analgesia / Q000379:methods; D000700:Analgesics; D000701:Analgesics, Opioid / Q000627:therapeutic use; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D004636:Emergency Service, Hospital; D005121:Extremities / Q000293:injuries; D005260:Female; D005283:Fentanyl / Q000008:administration & dosage / Q000627:therapeutic use*; D050723:Fractures, Bone / Q000150:complications*; D006801:Humans; D007649:Ketamine / Q000008:administration & dosage / Q000627:therapeutic use*; D008297:Male; D010146:Pain / Q000188:drug therapy* / Q000209:etiology; D010372:Pediatrics / Q000379:methods; D010865:Pilot Projects; D012107:Research Design; D016896:Treatment Outcome
D000700:Analgesics; D000701:Analgesics, Opioid; D007649:Ketamine; D005283:Fentanyl
PAIN MANAGEMENT; ketamine; pediatric orthopaedics