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

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: Intranasal sufentanil/ketamine

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 2

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Copenhagen University Hospital Rigshospitalet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 19 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sedation Score (UMSS)	University of Michigan Sedation Score (UMSS) (0-4, 0 "awake and alert", 4 "unarousable")	Time= 0-70 min. after drug administration
Acceptance of Intranasal Administration	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?	Immediately after the procedure

Collaborators and Investigators

• Sponsor: Danish University of Pharmaceutical Sciences
• Collaborators: Rigshospitalet, Denmark
• Investigators: Principal Investigator: Steen W Henneberg, MD DMSc, Rigshospitalet, Denmark; Principal Investigator: Kjeld Schmiegelow, MD DMSc, Copenhagen University Hospital Righospitalet

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Actual): February 1, 2013
• Study Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: January 8, 2010
• First Submitted That Met QC Criteria: January 11, 2010
• First Posted (Estimate): January 12, 2010

Study Record Updates

• Last Update Posted (Estimate): September 17, 2014
• Last Update Submitted That Met QC Criteria: September 12, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Keywords: Painful medical procedures
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Ketamine; Sufentanil
• Other Study ID Numbers: 201010; 2009-013801-33 (EudraCT Number)