Pain
Conditions
Brief summary
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.
Interventions
DRUGCT001
Intranasal
Sponsors
Cessatech A/S
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Pediatric participant, age 1 year to 17 years * Attending an Emergency Department following an injury * Acute pain of moderate or severe intensity * Obtained informed consent by parent/guardian and assent from the child if possible and relevant (age dependent)
Exclusion criteria
* Participant showing abnormal nasal cavity/airway such as: 1. major septal deviation 2. evidence of previous nasal disease or surgery 3. current significant nasal congestion due to common cold * Has received treatment with sufentanil and/or ketamine during the last 72 hours * Known or suspected allergy to ketamine or sufentanil * Critical, life- or limb-threatening condition requiring immediate management
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sedation | 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. | Sedation was assessed by sedation score on the University of Michigan Sedation Scale (UMSS). Scores range from 0 to 4, where 0 = awake/alert, 1 = minimally sedated (tired/sleepy, appropriate response to verbal conversation and/or sound), 2 = moderately sedated (somnolent/sleeping, easily aroused with light tactile stimulation or simple verbal command), 3 = deeply sedated (deep sleep, arousable only with significant physical stimulation), and 4 = unarousable. Lower scores indicate less sedation; higher scores indicate deeper sedation. |
| Respiratory Depression | At baseline and 10, 15, 20, 25, 30, 35, 45, 60 and 75 min after IMP administration. | Respiratory depression assessed by respiratory rate. |
| Peripheral Oxygen Saturation | At baseline and 10, 15, 20, 25, 30, 35, 45, 60 and 75 min after IMP administration. | Peripheral oxygen saturation assessed by oxygen saturation rate (%) |
| Cardiovascular Stability | At baseline and 10, 15, 20, 25, 30, 35, 45, 60 and 75 min after IMP administration. | Cardiovascular stability assessed by pulse rate (bpm) |
| Number of Reported Adverse Events | Through study completion; up to 7 days | Number of reported adverse events. |
| Number of Adverse Events (AEs) Reported Per Participant | Through study completion; up to 7 days | Number of adverse events (AEs) reported per participant. |
| Local Nasal Irritation | 30 and 60 min post IMP administration | The number of participants with nasal irritation was summarised using counts of participants for each timepoint (30 and 60 min post IMP administration) by type of nasal irritation. |
| Analgesic Effect | At baseline and at 15 and 30 min post first IMP dose | Number and proportion of participants that respond to the treatment relative to baseline (i.e. reduction in pain score to 4 or below). Pain intensity was assessed with age-appropriate validated scales. Ages ≥1-\<5years: FLACC (Face, Legs, Activity, Cry, Consolability), total score 0-10 (0=no pain, 10=severe pain). Ages ≥5-\<9years: Wong-Baker FACES, categories 0,2,4,6,8,10 (range 0-10; higher=worse pain). Ages ≥9years: Numerical Rating Scale (NRS) 0-10 (0=no pain, 10=worst pain imaginable). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Satisfaction | Prior to Emergency Department discharge (day of IMP administration) | Treatment satisfaction as assessed by responses to the question: "How satisfied are you with the study drug that you/your child received? Please think about how it helped their pain, how it was given, any side effects, and how quickly you/your child recovered". Respondents answered using a 5-point Likert scale (very unsatisfied (1), unsatisfied (2), neutral (3), satisfied (4), very satisfied (5)). |
| Feasibility (Acceptance of Nasal Administration) | Prior to Emergency Department discharge (day of IMP administration) | Feasibility (i.e. acceptance of nasal administration) was addressed by the healthcare staff asking the participant: "If you were in this situation again and needed pain medication, would you like to receive the nasal spray (relative to an injection, tablet or suppository for the pain)?' If not possible by the participant, the parent/legal guardian assessed nasal acceptability. Answers were "yes, "no", "I don't know". |
| Medication Errors | Assessed immediately post IMP administration | Medication errors, defined as any deviation in the IMP administration instructions that resulted in higher or lower dose than planned. Examples may include erroneous priming of the pump, too few/many pumps administered, etc. |
| Maximum Change From Baseline in Pain Intensity Within 30 Min Post (First) IMP Administration. | 30 min post (first) IMP administration | Pain intensity was assessed with age-appropriate validated scales. Ages ≥1-\<5years: FLACC (Face, Legs, Activity, Cry, Consolability), total score 0-10 (0=no pain, 10=severe pain). Ages ≥5-\<9years: Wong-Baker FACES, categories 0,2,4,6,8,10 (range 0-10; higher=worse pain). Ages ≥9years: Numerical Rating Scale (NRS) 0-10 (0=no pain, 10=worst pain imaginable). |
| Number of Participants That Achieved a 30% (or More) Reduction in Pain Intensity Relative to Baseline | within 30 min post (first) IMP administration. | Pain intensity was assessed with age-appropriate validated scales. Ages ≥1-\<5years: FLACC (Face, Legs, Activity, Cry, Consolability), total score 0-10 (0=no pain, 10=severe pain). Ages ≥5-\<9years: Wong-Baker FACES, categories 0,2,4,6,8,10 (range 0-10; higher=worse pain). Ages ≥9years: Numerical Rating Scale (NRS) 0-10 (0=no pain, 10=worst pain imaginable). |
| Change From Baseline in Pain Intensity | at 10, 15, 20, 30, 45 and 60 min post last dose of IMP administration. | Pain intensity was assessed with age-appropriate validated scales. Ages ≥1-\<5years: FLACC (Face, Legs, Activity, Cry, Consolability), total score 0-10 (0=no pain, 10=severe pain). Ages ≥5-\<9years: Wong-Baker FACES, categories 0,2,4,6,8,10 (range 0-10; higher=worse pain). Ages ≥9years: Numerical Rating Scale (NRS) 0-10 (0=no pain, 10=worst pain imaginable). |
| Number of Children Receiving Additional Analgesics | During the 60 min period post last dose of IMP | Number of children receiving additional analgesics. |
Countries
Spain, United Kingdom
Contacts
PRINCIPAL_INVESTIGATORStuart Hartshorn, Dr.
Birmingham Children's Hospital
Participant flow
Recruitment details
Total number of participants enrolled in the study: 155 (83 in Spain and 72 in the United Kingdom). There was no screen failures reported, only 1 participant was withdrawn from the study by the investigator due to pending surgical procedures which meant that the patient could not continue on the study. There were 155 participants in the full analysis set and in the safety population and 152 participants included in the efficacy analysis.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Customized Age 1 - < 5 years | 22 Participants |
| Age, Customized Age 5 - < 9 years | 38 Participants |
| Age, Customized Age 9 - < 18 years | 95 Participants |
| Baseline pain intensity score | 8 Score on a scale (0-10) |
| Ethnicity (NIH/OMB) Hispanic or Latino | 68 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 84 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Sex: Female, Male Female | 46 Participants |
| Sex: Female, Male Male | 109 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 155 |
| other Total, other adverse events | 73 / 155 |
| serious Total, serious adverse events | 4 / 155 |
Outcome results
None listed