The proposed study aims to investigate the safety, tolerability, analgesic efficacy, and feasibility of intranasal sufentanil/ketamine (CT001) in pediatric participants attending an acute care (i.e. emergency) setting. The study is a part of the clinical development plan for the development of CT001 nasal spray for treatment of acute pain in children.
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Sedation
Timeframe: At baseline and 10, 15, 20, 30, 45 and 60 min after first IMP administration. If a second IMP dose was needed, sedation score was performed at the timepoints relative to first IMP administration.
Respiratory Depression
Timeframe: At baseline and 10, 15, 20, 25, 30, 35, 45, 60 and 75 min after IMP administration.
Peripheral Oxygen Saturation
Timeframe: At baseline and 10, 15, 20, 25, 30, 35, 45, 60 and 75 min after IMP administration.
Cardiovascular Stability
Timeframe: At baseline and 10, 15, 20, 25, 30, 35, 45, 60 and 75 min after IMP administration.
Number of Reported Adverse Events
Timeframe: Through study completion; up to 7 days
Number of Adverse Events (AEs) Reported Per Participant
Timeframe: Through study completion; up to 7 days
Local Nasal Irritation
Timeframe: 30 and 60 min post IMP administration
Analgesic Effect
Timeframe: At baseline and at 15 and 30 min post first IMP dose