Trial Outcomes & Findings for Nasal Administration of Sufentanil+Ketamine for Procedure-related Pain in Children (NCT NCT01047241)

NCT ID: NCT01047241

Last Updated: 2014-09-17

Results Overview

Children \<5 years old were administered the FLACC (Face Leg Activity Cry Consolability) Scale (Range: 0-10, where 0 is no pain and 10 is worst pain). Children \>= 5 years but \< 8 years old were administered the Visual analog scale modified with six faces by Wong-Baker (Wong-Baker Faces Pain Rating Scale) (Range: 0-10, where 0 is no pain and 10 is worst pain). Children \>= 8 years old were administered a Visual Analog Scale (Range: 0-10, where 0 is no pain and 10 is worst pain).

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 50 participants
• Primary outcome timeframe: Pain assessment during painful medical procedure
• Results posted on: 2014-09-17

Participant Flow

Participant milestones

Measure	Intranasal Sufentanil+Ketamine Sufentanil, ketamine: Nasal spray sufentanil+ketamine, single dose
Overall Study STARTED	50
Overall Study COMPLETED	50
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Nasal Administration of Sufentanil+Ketamine for Procedure-related Pain in Children

Baseline characteristics by cohort

Measure	Intranasal Sufentanil+Ketamine n=50 Participants Sufentanil, ketamine: Nasal spray sufentanil+ketamine, single dose
Age, Continuous	8.8 years STANDARD_DEVIATION 4.9 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Sex: Female, Male Male	36 Participants n=5 Participants
Weight	34.9 kg STANDARD_DEVIATION 20.1 • n=5 Participants
Height	138.4 cm STANDARD_DEVIATION 32.0 • n=5 Participants
Preprocedural pain intensity	0.0 units on a scale n=5 Participants

PRIMARY outcome

Timeframe: Pain assessment during painful medical procedure

Children <5 years old were administered the FLACC (Face Leg Activity Cry Consolability) Scale (Range: 0-10, where 0 is no pain and 10 is worst pain). Children >= 5 years but < 8 years old were administered the Visual analog scale modified with six faces by Wong-Baker (Wong-Baker Faces Pain Rating Scale) (Range: 0-10, where 0 is no pain and 10 is worst pain). Children >= 8 years old were administered a Visual Analog Scale (Range: 0-10, where 0 is no pain and 10 is worst pain).

Outcome measures

Measure	Intranasal Sufentanil/Ketamine n=50 Participants Sufentanil/ketamine: Nasal spray containing a combination of sufentanil and ketamine. Dose sufentanil 0.5 micg/kg and ketamine 0.5 mg/kg, single dose
Procedural Pain Intensity Score	3.1 units on a scale Interval 2.0 to 4.9

PRIMARY outcome

Timeframe: Time= 5-60 min after administration of the investigational medical product

Outcome measures

Measure	Intranasal Sufentanil/Ketamine n=12 Participants Sufentanil/ketamine: Nasal spray containing a combination of sufentanil and ketamine. Dose sufentanil 0.5 micg/kg and ketamine 0.5 mg/kg, single dose
Maximum Plasma Concentration (Cmax) of Sufentanil and Ketamine Cmax sufentanil	0.042 mcg/L Standard Deviation 0.005 • Interval 0.151 to 0.277
Maximum Plasma Concentration (Cmax) of Sufentanil and Ketamine Cmax ketamine	102 mcg/L Standard Deviation 11

PRIMARY outcome

Timeframe: Time= 5-60 min after administration of the investigational medical product

Outcome measures

Measure	Intranasal Sufentanil/Ketamine n=12 Participants Sufentanil/ketamine: Nasal spray containing a combination of sufentanil and ketamine. Dose sufentanil 0.5 micg/kg and ketamine 0.5 mg/kg, single dose
Bioavailability of Sufentanil and Ketamine Bioavailability sufentanil	24.6 percentage bioavailable Standard Error 18.5
Bioavailability of Sufentanil and Ketamine Bioavailability ketamine	35.8 percentage bioavailable Standard Error 15.4

PRIMARY outcome

Timeframe: Time=5-60 min after administration of investigational medicinal product

Outcome measures

Measure	Intranasal Sufentanil/Ketamine n=12 Participants Sufentanil/ketamine: Nasal spray containing a combination of sufentanil and ketamine. Dose sufentanil 0.5 micg/kg and ketamine 0.5 mg/kg, single dose
Time to Maximum Plasma Concentrations (Tmax) Sufentanil and Ketamine Tmax sufentanil	13.8 minutes Standard Deviation 1.7
Time to Maximum Plasma Concentrations (Tmax) Sufentanil and Ketamine Tmax ketamine	8.5 minutes Standard Deviation 1.5

SECONDARY outcome

Timeframe: Time= 0-70 min. after drug administration

University of Michigan Sedation Score (UMSS) (0-4, 0 "awake and alert", 4 "unarousable")

Outcome measures

Measure	Intranasal Sufentanil/Ketamine n=50 Participants Sufentanil/ketamine: Nasal spray containing a combination of sufentanil and ketamine. Dose sufentanil 0.5 micg/kg and ketamine 0.5 mg/kg, single dose
Sedation Score (UMSS)	0 units on a scale Interval 0.0 to 2.0

SECONDARY outcome

Timeframe: Immediately after the procedure

Asking the children (parents for preverbal children) if they would like to receive this treatment again in a similar situation rather than analgesic suppositories, tablets, oral solutions, or injections?

Outcome measures

Measure	Intranasal Sufentanil/Ketamine n=50 Participants Sufentanil/ketamine: Nasal spray containing a combination of sufentanil and ketamine. Dose sufentanil 0.5 micg/kg and ketamine 0.5 mg/kg, single dose
Acceptance of Intranasal Administration	47 percentage of participants

Adverse Events

Intranasal Sufentanil+Ketamine

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Intranasal Sufentanil+Ketamine n=50 participants at risk Sufentanil, ketamine: Nasal spray sufentanil+ketamine, single dose
Gastrointestinal disorders Vomiting	4.0% 2/50

Additional Information

Sponsor's contact person Bettina Nygaard Nielsen

Copenhagen University Hospital, Rigshospitalet

Phone: +45 35459546

Email: bettina.nygaard.nielsen@regionh.dk

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place