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

Danish University of Pharmaceutical Sciences50 enrolled

Overview

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.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pain

Interventions

Intranasal sufentanil/ketamineDRUG

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

Eligibility

Sex: ALLMin age: 1 YearMax age: 19 Years

Medical Language ↔ Plain English

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)

Locations (1)

Copenhagen University Hospital Rigshospitalet

Copenhagen, Denmark

Outcomes

Primary Outcomes

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).

Time frame: Pain assessment during painful medical procedure

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

Secondary Outcomes

Sedation Score (UMSS)

University of Michigan Sedation Score (UMSS) (0-4, 0 "awake and alert", 4 "unarousable")

Time frame: 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?

Time frame: Immediately after the procedure

Data from ClinicalTrials.gov

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