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

This study has been completed.
Sponsor:
Collaborator:
Rigshospitalet, Denmark
Information provided by (Responsible Party):
Bettina Nygaard Nielsen, Danish University of Pharmaceutical Sciences
ClinicalTrials.gov Identifier:
NCT01047241
First received: January 8, 2010
Last updated: June 4, 2013
Last verified: June 2013

January 8, 2010
June 4, 2013
April 2010
February 2013   (final data collection date for primary outcome measure)
  • Pain score related to the medical painful procedure [ Time Frame: Time=0 and 30 min after administration of the ivestigational medical product ] [ Designated as safety issue: No ]
  • plasma concentrations of sufentanil and ketamine [ Time Frame: Time= 0, 5, 10, 15, 30, 60 min after administration of the investigational medical product ] [ Designated as safety issue: No ]
  • Pain score related to the medical painful procedure [ Time Frame: Time= 0 and 30 min (before and during medical procedure) ] [ Designated as safety issue: No ]
  • plasma concentrations of sufentanil and ketamine [ Time Frame: Time= 0, 5, 10, 15, 30, 60 min ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01047241 on ClinicalTrials.gov Archive Site
  • Sedation score [ Time Frame: Time= 0, 8, 20, 45, 70 min after administration of the investigational medical product ] [ Designated as safety issue: Yes ]
  • Accept of administration as nasal spray [ Time Frame: Time= 60 min after administration of the investigational medical product ] [ Designated as safety issue: No ]
  • Sedation score [ Time Frame: Time= 0, 8, 20, 45, 70 min ] [ Designated as safety issue: Yes ]
  • Accept of administration as nasal spray [ Time Frame: Time= 60 min ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Nasal Administration of Sufentanil+Ketamine for Procedure-related Pain in Children
Nasal Administration of Sufentanil+Ketamine for Procedure-related Pain in Children

The aim of the study is to investigate the absorption and clinical effect of nasal administration of sufentanil+ketamine (nasal spray) for procedure-related pain in hospitalized children.

Not Provided
Interventional
Phase 2
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Pain
Drug: Sufentanil, ketamine
Nasal spray sufentanil+ketamine, 0,5 microg/kg sufentanil+0,5 mg/kg ketamine, single dose
Experimental: Intranasal sufentanil+ketamine
Intervention: Drug: Sufentanil, ketamine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
February 2013
February 2013   (final data collection date for primary outcome measure)

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 nose strills
  • Have been treated with sufentanil and/or ketamine during the last 48 hours
  • Nasal obstruction (rhinitis)
Both
1 Year to 19 Years
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01047241
201010, 2009-013801-33
Yes
Bettina Nygaard Nielsen, Danish University of Pharmaceutical Sciences
Danish University of Pharmaceutical Sciences
Rigshospitalet, Denmark
Principal Investigator: Steen W Henneberg, MD DMSc Rigshospitalet, Denmark
Principal Investigator: Kjeld Schmiegelow, MD DMSc Copenhagen University Hospital Righospitalet
Danish University of Pharmaceutical Sciences
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP