Phase 2
Completed N=50
Nasal Administration of Sufentanil+Ketamine for Procedure-related Pain in Children
Source: ClinicalTrials.gov NCT01047241 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Sep 2014
Primary outcomePrimary: Procedural Pain Intensity Score — 3.1 units on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Procedural Pain Intensity Score |
3.1 | — |
| PRIMARY Maximum Plasma Concentration (Cmax) of Sufentanil and Ketamine |
0.042; 102 | — |
| PRIMARY Bioavailability of Sufentanil and Ketamine |
24.6; 35.8 | — |
| PRIMARY Time to Maximum Plasma Concentrations (Tmax) Sufentanil and Ketamine |
13.8; 8.5 | — |
| SECONDARY Sedation Score (UMSS) |
— | — |
| SECONDARY Acceptance of Intranasal Administration |
47 | — |
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT01047241). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.