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
Results First Received: January 6, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics/Dynamics Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Pain
Intervention: Drug: Intranasal sufentanil/ketamine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Intranasal Sufentanil+Ketamine Sufentanil, ketamine: Nasal spray sufentanil+ketamine, single dose

Participant Flow:   Overall Study
    Intranasal Sufentanil+Ketamine  
STARTED     50  
COMPLETED     50  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Intranasal Sufentanil+Ketamine Sufentanil, ketamine: Nasal spray sufentanil+ketamine, single dose

Baseline Measures
    Intranasal Sufentanil+Ketamine  
Number of Participants  
[units: participants]
  50  
Age  
[units: years]
Mean ± Standard Deviation
  8.8  ± 4.9  
Gender  
[units: participants]
 
Female     14  
Male     36  
Weight  
[units: kg]
Mean ± Standard Deviation
  34.9  ± 20.1  
Height  
[units: cm]
Mean ± Standard Deviation
  138.4  ± 32.0  
Preprocedural pain intensity  
[units: units on a scale]
Median ( Inter-Quartile Range )
  0.0  
  ( 0.0 to 2.0 )  



  Outcome Measures
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1.  Primary:   Procedural Pain Intensity Score   [ Time Frame: Pain assessment during painful medical procedure ]

2.  Primary:   Maximum Plasma Concentration (Cmax) of Sufentanil and Ketamine   [ Time Frame: Time= 5-60 min after administration of the investigational medical product ]

3.  Primary:   Bioavailability of Sufentanil and Ketamine   [ Time Frame: Time= 5-60 min after administration of the investigational medical product ]

4.  Primary:   Time to Maximum Plasma Concentrations (Tmax) Sufentanil and Ketamine   [ Time Frame: Time=5-60 min after administration of investigational medicinal product ]

5.  Secondary:   Sedation Score (UMSS)   [ Time Frame: Time= 0-70 min. after drug administration ]

6.  Secondary:   Acceptance of Intranasal Administration   [ Time Frame: Immediately after the procedure ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Sponsor's contact person Bettina Nygaard Nielsen
Organization: Copenhagen University Hospital, Rigshospitalet
phone: +45 35459546
e-mail: bettina.nygaard.nielsen@regionh.dk


No publications provided


Responsible Party: Bettina Nygaard Nielsen, Danish University of Pharmaceutical Sciences
ClinicalTrials.gov Identifier: NCT01047241     History of Changes
Other Study ID Numbers: 201010, 2009-013801-33
Study First Received: January 8, 2010
Results First Received: January 6, 2014
Last Updated: September 12, 2014
Health Authority: Denmark: Danish Medicines Agency