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

This study is currently recruiting participants.
Verified January 2013 by Danish University of Pharmaceutical Sciences
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: January 10, 2013
Last verified: January 2013
History of Changes
  Purpose

The aim of the study is to investigate the absorption and clinical effect of nasal administration of sufentanil+ketamine (nasal spray) for procedure-related pain in hospitalized children.


Condition Intervention Phase
Pain
 Drug: Sufentanil, ketamine
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Nasal Administration of Sufentanil+Ketamine for Procedure-related Pain in Children

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Danish University of Pharmaceutical Sciences:

Primary Outcome Measures:
  • Pain score related to the medical painful procedure [ Time Frame: Time=0 and 30 min after administration of the ivestigational medical product ] [ Designated as safety issue: No ]
  • plasma concentrations of sufentanil and ketamine [ Time Frame: Time= 0, 5, 10, 15, 30, 60 min after administration of the investigational medical product ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Sedation score [ Time Frame: Time= 0, 8, 20, 45, 70 min after administration of the investigational medical product ] [ Designated as safety issue: Yes ]
  • Accept of administration as nasal spray [ Time Frame: Time= 60 min after administration of the investigational medical product ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: April 2010
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intranasal sufentanil+ketamine Drug: Sufentanil, ketamine
Nasal spray sufentanil+ketamine, 0,5 microg/kg sufentanil+0,5 mg/kg ketamine, single dose

  Eligibility

Ages Eligible for Study:   1 Year to 19 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 nose strills
  • Have been treated with sufentanil and/or ketamine during the last 48 hours
  • Nasal obstruction (rhinitis)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01047241

Contacts
Contact: Bettina N Nielsen, MSc pharm +4535336228 bnn@farma.ku.dk

Locations
Denmark
Copenhagen University Hospital Rigshospitalet Recruiting
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Danish University of Pharmaceutical Sciences
Rigshospitalet, Denmark
Investigators
Principal Investigator: Steen W Henneberg, MD DMSc Rigshospitalet, Denmark
Principal Investigator: Kjeld Schmiegelow, MD DMSc Copenhagen University Hospital Righospitalet
  More Information

No publications provided

Responsible Party: Bettina Nygaard Nielsen, M.Sc. Pharm. sponsor contact person, 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
Last Updated: January 10, 2013
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by Danish University of Pharmaceutical Sciences:
Painful medical procedures

Additional relevant MeSH terms:
Ketamine
Sufentanil
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
 Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Adjuvants, Anesthesia
Narcotics

ClinicalTrials.gov processed this record on May 19, 2013