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).
Nasal Administration of Sufentanil+Ketamine for Procedure-related Pain in Children
Brief Summary
The aim of the study is to investigate the absorption and clinical effect of nasal administration of an analgesic nasal spray containing sufentanil+ketamine for pain related to medical procedures in hospitalized children.
Intervention / Treatment
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Intranasal sufentanil/ketamine (DRUG)Nasal spray sufentanil+ketamine, 0,5 microg/kg sufentanil+0,5 mg/kg ketamine, single dose
Condition or Disease
- Pain
Phase
Study Design
| Study type: | INTERVENTIONAL |
|---|---|
| Status: | Completed |
| Study results: | No Results Available |
| Age: | 1 Year to 19 Years |
| Enrollment: | 50 (ACTUAL) |
| Funded by: | Other |
| Allocation: | N/A |
| Primary Purpose: | Treatment |
Masking |
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Clinical Trial Dates
| Start date: | Apr 01, 2010 | |
|---|---|---|
| Primary Completion: | Feb 01, 2013 | ACTUAL |
| Completion Date: | Feb 01, 2013 | ACTUAL |
| Study First Posted: | Jan 12, 2010 | ESTIMATED |
| Results First Posted: | Sep 17, 2014 | ESTIMATED |
| Last Updated: | Sep 12, 2014 |
Sponsors / Collaborators
Lead Sponsor:
Danish University of Pharmaceutical Sciences
Responsible Party:
N/A
Location
The management of procedural pain in children ranges from physical restraint to pharmacological interventions. Pediatric formulations that permit accurate dosing, are accepted by children and a have a rapid onset of analgesia are lacking. The objectives were to investigate a pediatric formulation of intranasal sufentanil 0.5 mcg/kg and ketamine 0.5 mg/kg for procedural pain and to characterize the pharmacokinetic (PK) profile. Fifty children (≥10 kg) scheduled for a painful procedure were included in this prospective nonrandomized open-label clinical trial. Thirteen of these children had central venous access for drug assay sampling; enabling a compartmental PK analysis using nonlinear mixed-effects models. Pain intensity before and during the procedure was measured using age-appropriate pain scales. Heart rate, oxygen saturation and sedation were recorded.
Participant Groups
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Intranasal combination of sufentanil and ketamine. Dose of sufentanil 0.5 mcg/kg and ketamine 0.5 mg/kg, single dose.
Eligibility Criteria
| Sex: | All |
|---|---|
| Minimum Age: | 1 |
| Maximum Age: | 19 |
| Age Groups: | Child / Adult |
| Healthy Volunteers: | Yes |
Inclusion Criteria:
* Children and adolescents treated at the University Hospital, Rigshospital
* Painful medical procedure related to the patients treatment
* Patient and/or the parents must be able to understand and speak danish
* Negative pregnancy test for girls, when relevant
* Signed informed consent
* Only a light meals or no meals have been ingested 2 hours prior to inclusion
Exclusion Criteria:
* Allergy to sufentanil or ketamine
* Abnormal nasal cavity
* Have been treated with sufentanil and/or ketamine during the last 48 hours
* Nasal obstruction (rhinitis)
* Children and adolescents treated at the University Hospital, Rigshospital
* Painful medical procedure related to the patients treatment
* Patient and/or the parents must be able to understand and speak danish
* Negative pregnancy test for girls, when relevant
* Signed informed consent
* Only a light meals or no meals have been ingested 2 hours prior to inclusion
Exclusion Criteria:
* Allergy to sufentanil or ketamine
* Abnormal nasal cavity
* Have been treated with sufentanil and/or ketamine during the last 48 hours
* Nasal obstruction (rhinitis)
Primary Outcomes
-
-
Maximum Plasma Concentration (Cmax) of Sufentanil and Ketamine Time= 5-60 min after administration of the investigational medical product
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Bioavailability of Sufentanil and Ketamine Time= 5-60 min after administration of the investigational medical product
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Time to Maximum Plasma Concentrations (Tmax) Sufentanil and Ketamine Time=5-60 min after administration of investigational medicinal product
Secondary Outcomes
-
University of Michigan Sedation Score (UMSS) (0-4, 0 "awake and alert", 4 "unarousable")
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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?
More Details
| NCT Number: | NCT01047241 |
|---|---|
| Other IDs: | 201010 |
| Study URL: | https://clinicaltrials.gov/study/NCT01047241 |
Last updated: Sep 29, 2023