Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  Purpose

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.


Condition Intervention Phase
Pain
Drug: Intranasal 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:


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

Primary Outcome Measures:
  • Procedural Pain Intensity Score [ Time Frame: Pain assessment during painful medical procedure ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Bioavailability of Sufentanil and Ketamine [ Time Frame: Time= 5-60 min after administration of the investigational medical product ] [ Designated as safety issue: No ]
  • Time to Maximum Plasma Concentrations (Tmax) Sufentanil and Ketamine [ Time Frame: Time=5-60 min after administration of investigational medicinal product ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Sedation Score (UMSS) [ Time Frame: Time= 0-70 min. after drug administration ] [ Designated as safety issue: Yes ]
    University of Michigan Sedation Score (UMSS) (0-4, 0 "awake and alert", 4 "unarousable")

  • Acceptance of Intranasal Administration [ Time Frame: Immediately after the procedure ] [ Designated as safety issue: No ]
    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?


Enrollment: 50
Study Start Date: April 2010
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  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 nasal cavity
  • Have been treated with sufentanil and/or ketamine during the last 48 hours
  • Nasal obstruction (rhinitis)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01047241

Locations
Denmark
Copenhagen University Hospital Rigshospitalet
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
Results First Received: January 6, 2014
Last Updated: September 12, 2014
Health Authority: Denmark: Danish Medicines Agency

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

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

ClinicalTrials.gov processed this record on November 23, 2014