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
|Condition or disease||Intervention/treatment||Phase|
|Pain||Drug: Intranasal sufentanil/ketamine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Nasal Administration of Sufentanil+Ketamine for Procedure-related Pain in Children|
|Study Start Date :||April 2010|
|Actual Primary Completion Date :||February 2013|
|Actual Study Completion Date :||February 2013|
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.
Drug: Intranasal sufentanil/ketamine
Nasal spray sufentanil+ketamine, 0,5 microg/kg sufentanil+0,5 mg/kg ketamine, single dose
- 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 ]
- 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?
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01047241
|Copenhagen University Hospital Rigshospitalet|
|Copenhagen, Denmark, 2100|
|Principal Investigator:||Steen W Henneberg, MD DMSc||Rigshospitalet, Denmark|
|Principal Investigator:||Kjeld Schmiegelow, MD DMSc||Copenhagen University Hospital Righospitalet|