NCT01047241

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2 pain

Timeline
Completed

Started Apr 2010

Typical duration for phase_2 pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 8, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 12, 2010

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2010

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

September 17, 2014

Completed
Last Updated

September 17, 2014

Status Verified

September 1, 2014

Enrollment Period

2.8 years

First QC Date

January 8, 2010

Results QC Date

January 6, 2014

Last Update Submit

September 12, 2014

Conditions

Pain

Keywords

Painful medical procedures

Outcome Measures

Primary Outcomes (4)

  • Procedural Pain Intensity Score

    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).

    Pain assessment during painful medical procedure

  • Maximum Plasma Concentration (Cmax) of Sufentanil and Ketamine

    Time= 5-60 min after administration of the investigational medical product

  • Bioavailability of Sufentanil and Ketamine

    Time= 5-60 min after administration of the investigational medical product

  • Time to Maximum Plasma Concentrations (Tmax) Sufentanil and Ketamine

    Time=5-60 min after administration of investigational medicinal product

Secondary Outcomes (2)

  • Sedation Score (UMSS)

    Time= 0-70 min. after drug administration

  • Acceptance of Intranasal Administration

    Immediately after the procedure

Study Arms (1)

Intranasal sufentanil/ketamine

EXPERIMENTAL

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

Interventions

Intranasal sufentanil/ketamineDRUG

Nasal spray sufentanil+ketamine, 0,5 microg/kg sufentanil+0,5 mg/kg ketamine, single dose

Intranasal sufentanil/ketamine

Eligibility Criteria

Age1 Year - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Allergy to sufentanil or ketamine
  • Abnormal nasal cavity
  • Have been treated with sufentanil and/or ketamine during the last 48 hours
  • Nasal obstruction (rhinitis)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Copenhagen University Hospital Rigshospitalet

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Pain

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Results Point of Contact

Title
Sponsor's contact person Bettina Nygaard Nielsen
Organization
Copenhagen University Hospital, Rigshospitalet
bettina.nygaard.nielsen@regionh.dk
+45 35459546

Study Officials

  • Steen W Henneberg, MD DMSc

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

  • Kjeld Schmiegelow, MD DMSc

    Copenhagen University Hospital Righospitalet

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.Sc. Pharm. sponsor contact person

Study Record Dates

First Submitted

January 8, 2010

First Posted

January 12, 2010

Study Start

April 1, 2010

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

September 17, 2014

Results First Posted

September 17, 2014

Record last verified: 2014-09

Locations

DK(1)