PainPhase 2NCT01047241
Nasal Administration of Sufentanil+Ketamine for Procedure-related Pain in Children
A Phase 2 study testing Intranasal sufentanil/ketamine in people with Pain, run by Danish University of Pharmaceutical Sciences at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 19 years
- Conditions the study is for
- Pain
- What is being tested?
- Intranasal sufentanil/ketamine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2010to Feb 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Allergy to sufentanil or ketamine
- Abnormal nasal cavity
- Have been treated with sufentanil and/or ketamine during the last 48 hours
- Nasal obstruction (rhinitis)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Pain
- Being tested
- Intranasal sufentanil/ketamine
- Keywords
- Painful medical procedures
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intranasal sufentanil/ketamineDrug
Nasal spray sufentanil+ketamine, 0,5 microg/kg sufentanil+0,5 mg/kg ketamine, single dose
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Intranasal sufentanil/ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Pain assessment during painful medical procedure
Maximum Plasma Concentration (Cmax) of Sufentanil and Ketamine
Measured: Time= 5-60 min after administration of the investigational medical product
Bioavailability of Sufentanil and Ketamine
Measured: Time= 5-60 min after administration of the investigational medical product
Time to Maximum Plasma Concentrations (Tmax) Sufentanil and Ketamine
Measured: Time=5-60 min after administration of investigational medicinal product
Secondary outcomes (2)
Sedation Score (UMSS)
University of Michigan Sedation Score (UMSS) (0-4, 0 "awake and alert", 4 "unarousable")
Measured: 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?
Measured: Immediately after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2010 (estimated)
- Study startApr 2010
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danish University of Pharmaceutical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet
- Responsible party
- Principal investigator, Bettina Nygaard Nielsen, Danish University of Pharmaceutical Sciences
- Investigators
- Steen W Henneberg, MD DMSc, Principal investigator, Copenhagen University Hospital, RigshospitaletKjeld Schmiegelow, MD DMSc, Principal investigator, Copenhagen University Hospital Righospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01047241
- Sponsor's protocol ID
- 201010
- Other IDs
- 2009-013801-33, 2009
- Status last verified
- Sep 2014
- First submitted
- 8 Jan 2010
- Last updated
- 17 Sep 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nasal Administration of Sufentanil+Ketamine for Procedure-related Pain in Children
- ClinicalTrials.gov ID
- NCT01047241
- Acronym / sponsor ID
- 201010
- Conditions
- Pain
- Keywords
- Painful medical procedures
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Danish University of Pharmaceutical SciencesUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet
- Study start
- Apr 2010
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 12 Jan 2010 (estimated)
- Results
- Posted 17 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intranasal sufentanil/ketamine | Experimental | Drug: Intranasal sufentanil/ketamineIntranasal combination of sufentanil and ketamine. Dose of sufentanil 0.5 mcg/kg and ketamine 0.5 mg/kg, single dose. |
Who may qualify
- Ages
- 1 year to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- Allergy to sufentanil or ketamine
- Abnormal nasal cavity
- Have been treated with sufentanil and/or ketamine during the last 48 hours
- Nasal obstruction (rhinitis)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intranasal sufentanil/ketamineNasal spray sufentanil+ketamine, 0,5 microg/kg sufentanil+0,5 mg/kg ketamine, single dose | Drug | Intranasal sufentanil/ketamine |
Primary outcome
Procedural Pain Intensity Score
Time frame: Pain assessment during painful medical procedure
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
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
2 secondary outcomes
Sedation Score (UMSS)
Time frame: Time= 0-70 min. after drug administration
Acceptance of Intranasal Administration
Time frame: Immediately after the procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steen W Henneberg, MD DMSc principal investigator
Copenhagen University Hospital, Rigshospitalet
Kjeld Schmiegelow, MD DMSc principal investigator
Copenhagen University Hospital Righospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Intranasal sufentanil/ketamine in people with Pain, run by Danish University of Pharmaceutical Sciences at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedural Pain Intensity Score (time frame: Pain assessment during painful medical procedure). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2014.