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

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ClinicalTrials.gov Identifier: NCT01047241
Recruitment Status : Completed
First Posted : January 12, 2010
Results First Posted : September 17, 2014
Last Update Posted : September 17, 2014
Sponsor:
Collaborator:
Rigshospitalet, Denmark
Information provided by (Responsible Party):
Bettina Nygaard Nielsen, Danish University of Pharmaceutical Sciences

Tracking Information
First Submitted Date  ICMJE January 8, 2010
First Posted Date  ICMJE January 12, 2010
Results First Submitted Date  ICMJE January 6, 2014
Results First Posted Date  ICMJE September 17, 2014
Last Update Posted Date September 17, 2014
Study Start Date  ICMJE April 2010
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 12, 2014)
  • Procedural Pain Intensity Score [ Time Frame: 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).
  • Maximum Plasma Concentration (Cmax) of Sufentanil and Ketamine [ Time Frame: Time= 5-60 min after administration of the investigational medical product ]
  • Bioavailability of Sufentanil and Ketamine [ Time Frame: Time= 5-60 min after administration of the investigational medical product ]
  • Time to Maximum Plasma Concentrations (Tmax) Sufentanil and Ketamine [ Time Frame: Time=5-60 min after administration of investigational medicinal product ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 11, 2010)
  • Pain score related to the medical painful procedure [ Time Frame: Time= 0 and 30 min (before and during medical procedure) ]
  • plasma concentrations of sufentanil and ketamine [ Time Frame: Time= 0, 5, 10, 15, 30, 60 min ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 12, 2014)
  • Sedation Score (UMSS) [ Time Frame: Time= 0-70 min. after drug administration ]
    University of Michigan Sedation Score (UMSS) (0-4, 0 "awake and alert", 4 "unarousable")
  • Acceptance of Intranasal Administration [ Time Frame: 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?
Original Secondary Outcome Measures  ICMJE
 (submitted: January 11, 2010)
  • Sedation score [ Time Frame: Time= 0, 8, 20, 45, 70 min ]
  • Accept of administration as nasal spray [ Time Frame: Time= 60 min ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Nasal Administration of Sufentanil+Ketamine for Procedure-related Pain in Children
Official Title  ICMJE 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.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pain
Intervention  ICMJE Drug: Intranasal sufentanil/ketamine
Nasal spray sufentanil+ketamine, 0,5 microg/kg sufentanil+0,5 mg/kg ketamine, single dose
Study Arms  ICMJE 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 11, 2010)
50
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2013
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year to 19 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01047241
Other Study ID Numbers  ICMJE 201010
2009-013801-33 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bettina Nygaard Nielsen, Danish University of Pharmaceutical Sciences
Study Sponsor  ICMJE Danish University of Pharmaceutical Sciences
Collaborators  ICMJE Rigshospitalet, Denmark
Investigators  ICMJE
Principal Investigator: Steen W Henneberg, MD DMSc Rigshospitalet, Denmark
Principal Investigator: Kjeld Schmiegelow, MD DMSc Copenhagen University Hospital Righospitalet
PRS Account Danish University of Pharmaceutical Sciences
Verification Date September 2014

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