SMR-3965
Research type
Research Study
Full title
Open-label, prospective study to assess the safety, tolerability, analgesic effect and feasibility of IN SUF/KET in pediatric patients with moderate or severe pain, in an acute care setting.
IRAS ID
1006944
Contact name
Amanda Knock
Contact email
Sponsor organisation
Cessatech A/S
Clinicaltrials.gov Identifier
Research summary
This is a phase 3 multi-national (UK and Spain) multi-centre (approx. 6 sites) study where participants aged 1 to 17 years will be treated with an nasal spray containing CT1001 (sufentanil and ketamine) for moderate or severe pain from a physical wound or injury. CT1001 relieves pain, is calming and induces sleepiness.
Despite the many pain-relieving products available for adult patients, few of these have been developed for children and there is a significant unmet medical need for treatment of acute pain in this population.
The nasal spray formulation of CT1001 has several advantages over other pain management delivery methods including needle free administration, ease of administration and rapid onset of effects.
The purpose of this study is to investigate the safety and efficacy of CT1001 in paediatric patients with moderate or severe pain. Approximately 150 participants will be included in this study who present at the emergency department of the hospital. They will be reviewed for eligibility into the study, their vital signs reviewed, and pain assessed. Each participant will receive one or two doses of nasal CT1001 with 10 to 15 minutes in between. After each dose pain will be assessed using pain scales. Participants or parents / legal guardians will receive a follow-up phone call 2 to 7 days later to check on their health.REC name
East of Scotland Research Ethics Service REC 2
REC reference
23/ES/0027
Date of REC Opinion
21 Sep 2023
REC opinion
Further Information Favourable Opinion