Safety, Tolerability, Analgesic Effect, and Feasibility of Intranasal CT001 in Pediatric Patients

Cessatech A/S155 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

155

Conditions

Pain

Interventions

CT001DRUG

Intranasal

Eligibility

Sex: ALLMin age: 1 YearMax age: 17 Years

Medical Language ↔ Plain English

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

Locations (7)

Hospital General Universitario Dr. Balmis

Alicante, Spain

Hospital Sant Joan de Deu

Barcelona, Spain

Universidad Autonoma de Madrid (UAM) - Hospital Universitario La Paz (HULP) -

Madrid, Spain

Complejo Hospitalario Universitario de Santiago (CHUS)

Santiago de Compostela, Spain

Outcomes

Primary Outcomes

Sedation

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.

Time frame: 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

Respiratory depression assessed by respiratory rate.

Time frame: At baseline and 10, 15, 20, 25, 30, 35, 45, 60 and 75 min after IMP administration.

Peripheral Oxygen Saturation

Peripheral oxygen saturation assessed by oxygen saturation rate (%)

Time frame: At baseline and 10, 15, 20, 25, 30, 35, 45, 60 and 75 min after IMP administration.

Cardiovascular Stability

Cardiovascular stability assessed by pulse rate (bpm)

Time frame: At baseline and 10, 15, 20, 25, 30, 35, 45, 60 and 75 min after IMP administration.

Number of Reported Adverse Events

Number of reported adverse events.

Time frame: Through study completion; up to 7 days

Number of Adverse Events (AEs) Reported Per Participant

Number of adverse events (AEs) reported per participant.

Time frame: Through study completion; up to 7 days

Data from ClinicalTrials.gov

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Secondary Outcomes

Treatment Satisfaction

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)).

Time frame: Prior to Emergency Department discharge (day of IMP administration)

Feasibility (Acceptance of Nasal 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".

Time frame: Prior to Emergency Department discharge (day of IMP administration)

Medication Errors

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.

Time frame: Assessed immediately post IMP administration

Maximum Change From Baseline in Pain Intensity 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).

Time frame: 30 min post (first) IMP administration

Number of Participants That Achieved a 30% (or More) Reduction in Pain Intensity Relative to Baseline

Time frame: within 30 min post (first) IMP administration.

Change From Baseline in Pain Intensity

Time frame: at 10, 15, 20, 30, 45 and 60 min post last dose of IMP administration.

Number of Children Receiving Additional Analgesics

Number of children receiving additional analgesics.

Time frame: During the 60 min period post last dose of IMP