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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: September 12, 2014
Last verified: September 2014

January 8, 2010
September 12, 2014
April 2010
February 2013   (final data collection date for primary outcome measure)
  • Procedural Pain Intensity Score [ Time Frame: Pain assessment during painful medical procedure ] [ Designated as safety issue: No ]
    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).
  • Maximum Plasma Concentration (Cmax) of Sufentanil and Ketamine [ Time Frame: Time= 5-60 min after administration of the investigational medical product ] [ Designated as safety issue: No ]
  • Bioavailability of Sufentanil and Ketamine [ Time Frame: Time= 5-60 min after administration of the investigational medical product ] [ Designated as safety issue: No ]
  • Time to Maximum Plasma Concentrations (Tmax) Sufentanil and Ketamine [ Time Frame: Time=5-60 min after administration of investigational medicinal 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 (UMSS) [ Time Frame: Time= 0-70 min. after drug administration ] [ Designated as safety issue: Yes ]
    University of Michigan Sedation Score (UMSS) (0-4, 0 "awake and alert", 4 "unarousable")
  • Acceptance of Intranasal Administration [ Time Frame: Immediately after the procedure ] [ Designated as safety issue: No ]
    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?
  • 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 an analgesic nasal spray containing sufentanil+ketamine for pain related to medical procedures in hospitalized children.

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.

Interventional
Phase 2
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Pain
Drug: Intranasal sufentanil/ketamine
Nasal spray sufentanil+ketamine, 0,5 microg/kg sufentanil+0,5 mg/kg ketamine, single dose
Experimental: Intranasal sufentanil/ketamine
Intranasal combination of sufentanil and ketamine. Dose of sufentanil 0.5 mcg/kg and ketamine 0.5 mg/kg, single dose.
Intervention: Drug: Intranasal 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 nasal cavity
  • 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
No
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
September 2014

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