AbscessPhase 4NCT02635282
IN Ketamine Vs IN Midazolam and Fentanyl for Abscess I&D
A Phase 4 study testing intranasal ketamine, intranasal fentanyl and intranasal midazolam in people with Abscess and Pain, run by University of Tennessee at 1 site in United States.
Trial summary
The general objective of this study is to determine whether intranasal ketamine should be incorporated into formulary as an option to treat pain during minor procedures in the pediatric emergency department. Read more about this study
- Who is it for?
- Ages 3 to 17 yearsHealthy volunteers can take part
- What is being tested?
- intranasal ketamine, intranasal fentanyl and intranasal midazolam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to 23 Mar 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 3 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Diagnosis of abscess with planned incision and drainage of a single abscess
Who cannot join
- Fast Track patients
- Patients who have received an opioid analgesic within the previous 4 hours of time of enrollment in study
- Patients with parent or legal guardian not present to give informed consent for enrollment in study
- Non-English speaking patients and/or parent
- Patients with a contraindication for the administration of intranasal medication (nasal trauma, aberrant nasal anatomy)
- Patients with ocular injuries
Show all 9Show fewer
- Patients with a known allergy to ketamine, fentanyl, and/or midazolam
- Pregnant females
- Patients with history of seizure disorders
Trial locations and contacts
1 site in 1 country.
United States1 site
Le Bonheur Children's Hospital
Memphis, Tennessee, 38105
About this study
Official title: Intranasal Ketamine Versus Intranasal Midazolam Plus Fentanyl in Treating Pain Associated With Incision and Drainage of Abscesses in the Pediatric Emergency Department: A Randomized Controlled Trial
The general objective of this study is to determine whether intranasal ketamine should be incorporated into formulary as an option to treat pain during minor procedures in the pediatric emergency department.
Read the detailed description
In the pediatric emergency department, one of the main goals in patient care is to provide adequate pain management. Many patients present to the emergency department with conditions or injuries that cause acute or chronic pain. Health care providers routinely aim to treat patients' pain in a timely manner after arrival to the emergency department. A common scenario occurs when a patient presents with a condition in which treatment will require that a potentially painful or anxiety-provoking procedure will be performed in the ED, and providers also strive to treat this pain and anxiety accordingly. There are several different methods for treating pain and anxiety, including multiple types of medications, which can be given orally, intravenously, intramuscularly, or intranasally. The use of intranasal medications for the treatment of pain and anxiety has been steadily increasing over the last decade, and this has been particularly helpful in the pediatric population. There are several advantages of using intranasal medications, including rapid onset, ease of administration, and lack of need for IV access.
At this time, this pediatric emergency department uses two different medications via the intranasal route of administration: fentanyl, a synthetic opiate, and midazolam, a benzodiazepine, which are used for pain control and anxiolysis, respectively, and these two medications are frequently used together. The objective of this study is to introduce ketamine as a third medication for intranasal use and to observe its effects on pain control; this medication is currently used either intravenously or intramuscularly in the investigator's ED. Ketamine is an anesthetic that has properties of analgesia and amnesia and has a generally favorable side effect profile. This study will observe the effects of using a medication that is already widely used in the investigator's ED, but it will be used via a different route of administration, offering advantages over other options. In this study, patients will be enrolled who have been diagnosed with a soft tissue abscess that will be treated with incision and drainage in the ED. Patients in one group will be given a dose of intranasal ketamine at a predetermined dose, and measured variables will include pain score, vital signs, patient and/or parent satisfaction, adverse effects, length of stay, and need for additional doses of ketamine or additional medications. This group of patients will be compared with another group of patients who will be given intranasal fentanyl and intranasal midazolam using a randomization through the RedCap system. The investigators hypothesize that the use of intranasal ketamine in this PED for treating pain associated with the minor procedure of incision and drainage of a soft tissue abscess will provide satisfactory pain control in these patients while offering advantages over other treatment options, as compared with patients treated with the current standard intranasal medications.
- Being tested
- intranasal ketamine, intranasal fentanyl, intranasal midazolam
- Medical subject headings
- Abscess, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intranasal ketamineDrug
intranasal fentanylDrug
intranasal midazolamDrug
Also called Versed
| Study group | Role | What they receive |
|---|---|---|
| IN fentanyl and midazolam | Active comparator | group of patients who are randomized to receive intranasal fentanyl and midazolam Receives: Drug: intranasal fentanyl; Drug: intranasal midazolam |
| IN ketamine | Experimental | group of patients who are randomized to receive intranasal ketamine Receives: Drug: intranasal ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain score measured utilizing the Faces Pain Scale-Revised
The Faces Pain Scale-Revised will be used for children ages 3-7 years
Measured: before medication administered and at 30 minutes after medication administration
Change in pain score measured utilizing the numeric pain rating scale
The numeric pain rating scale will be used in children ages 8-17 years
Measured: before medication administered and at 30 minutes after medication administration
Secondary outcomes (2)
Vital sign measurements
Temperature, heart rate, respiratory rate, oxygen saturation, and blood pressure will be measured
Measured: before medication administered and at 15 and 30 minutes after medication administration
Sedation score using the University of Michigan Sedation Scale
Measured: before medication administered and at 15 and 30 minutes after medication administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2015 (estimated)
- Study startAug 2016
- Primary completion23 Mar 2017
- Study completion23 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for AbscessStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tennessee
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cynthia Copley, University of Tennessee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02635282
- Sponsor's protocol ID
- 15-04113-FB
- Status last verified
- Mar 2017
- First submitted
- 9 Dec 2015
- Last updated
- 27 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Bailey B, Gravel J, Daoust R. Reliability of the visual analog scale in children with acute pain in the emergency department. Pain. 2012 Apr;153(4):839-842. doi: 10.1016/j.pain.2012.01.006. Epub 2012 Feb 4.
PubMed 22305630Afridi SK, Giffin NJ, Kaube H, Goadsby PJ. A randomized controlled trial of intranasal ketamine in migraine with prolonged aura. Neurology. 2013 Feb 12;80(7):642-7. doi: 10.1212/WNL.0b013e3182824e66. Epub 2013 Jan 30.
PubMed 23365053Andolfatto G, Willman E, Joo D, Miller P, Wong WB, Koehn M, Dobson R, Angus E, Moadebi S. Intranasal ketamine for analgesia in the emergency department: a prospective observational series. Acad Emerg Med. 2013 Oct;20(10):1050-4. doi: 10.1111/acem.12229.
PubMed 24127709Del Pizzo J, Callahan JM. Intranasal medications in pediatric emergency medicine. Pediatr Emerg Care. 2014 Jul;30(7):496-501; quiz 502-4. doi: 10.1097/PEC.0000000000000171.
PubMed 24987995
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intranasal Ketamine Versus Intranasal Midazolam Plus Fentanyl in Treating Pain Associated With Incision and Drainage of Abscesses in the Pediatric Emergency Department: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02635282
- Acronym / sponsor ID
- 15-04113-FB
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of TennesseeUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- 23 Mar 2017 (actual)
- Study completion
- 23 Mar 2017 (actual)
- First posted
- 18 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The general objective of this study is to determine whether intranasal ketamine should be incorporated into formulary as an option to treat pain during minor procedures in the pediatric emergency department.
Detailed description
In the pediatric emergency department, one of the main goals in patient care is to provide adequate pain management. Many patients present to the emergency department with conditions or injuries that cause acute or chronic pain. Health care providers routinely aim to treat patients' pain in a timely manner after arrival to the emergency department. A common scenario occurs when a patient presents with a condition in which treatment will require that a potentially painful or anxiety-provoking procedure will be performed in the ED, and providers also strive to treat this pain and anxiety accordingly. There are several different methods for treating pain and anxiety, including multiple types of medications, which can be given orally, intravenously, intramuscularly, or intranasally. The use of intranasal medications for the treatment of pain and anxiety has been steadily increasing over the last decade, and this has been particularly helpful in the pediatric population. There are several advantages of using intranasal medications, including rapid onset, ease of administration, and lack of need for IV access.
At this time, this pediatric emergency department uses two different medications via the intranasal route of administration: fentanyl, a synthetic opiate, and midazolam, a benzodiazepine, which are used for pain control and anxiolysis, respectively, and these two medications are frequently used together. The objective of this study is to introduce ketamine as a third medication for intranasal use and to observe its effects on pain control; this medication is currently used either intravenously or intramuscularly in the investigator's ED. Ketamine is an anesthetic that has properties of analgesia and amnesia and has a generally favorable side effect profile. This study will observe the effects of using a medication that is already widely used in the investigator's ED, but it will be used via a different route of administration, offering advantages over other options. In this study, patients will be enrolled who have been diagnosed with a soft tissue abscess that will be treated with incision and drainage in the ED. Patients in one group will be given a dose of intranasal ketamine at a predetermined dose, and measured variables will include pain score, vital signs, patient and/or parent satisfaction, adverse effects, length of stay, and need for additional doses of ketamine or additional medications. This group of patients will be compared with another group of patients who will be given intranasal fentanyl and intranasal midazolam using a randomization through the RedCap system. The investigators hypothesize that the use of intranasal ketamine in this PED for treating pain associated with the minor procedure of incision and drainage of a soft tissue abscess will provide satisfactory pain control in these patients while offering advantages over other treatment options, as compared with patients treated with the current standard intranasal medications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IN fentanyl and midazolam | Active comparator | Drug: intranasal fentanyl, Drug: intranasal midazolamgroup of patients who are randomized to receive intranasal fentanyl and midazolam |
| IN ketamine | Experimental | Drug: intranasal ketaminegroup of patients who are randomized to receive intranasal ketamine |
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Diagnosis of abscess with planned incision and drainage of a single abscess
Key exclusion criteria (9 listed)
- Fast Track patients
- Patients who have received an opioid analgesic within the previous 4 hours of time of enrollment in study
- Patients with parent or legal guardian not present to give informed consent for enrollment in study
- Non-English speaking patients and/or parent
- Patients with a contraindication for the administration of intranasal medication (nasal trauma, aberrant nasal anatomy)
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 ketamine | Drug | IN ketamine |
| intranasal fentanyl | Drug | IN fentanyl and midazolam |
| intranasal midazolamAlso: Versed | Drug | IN fentanyl and midazolam |
Primary outcome
Change in pain score measured utilizing the Faces Pain Scale-Revised
Time frame: before medication administered and at 30 minutes after medication administration
The Faces Pain Scale-Revised will be used for children ages 3-7 years
Change in pain score measured utilizing the numeric pain rating scale
Time frame: before medication administered and at 30 minutes after medication administration
The numeric pain rating scale will be used in children ages 8-17 years
2 secondary outcomes
Vital sign measurements
Time frame: before medication administered and at 15 and 30 minutes after medication administration
Sedation score using the University of Michigan Sedation Scale
Time frame: before medication administered and at 15 and 30 minutes after medication administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2017.
- Background: PubMed 22305630Bailey B, Gravel J, Daoust R. Reliability of the visual analog scale in children with acute pain in the emergency department. Pain. 2012 Apr;153(4):839-842. doi: 10.1016/j.pain.2012.01.006. Epub 2012 Feb 4.
- Results publication: PubMed 23365053Afridi SK, Giffin NJ, Kaube H, Goadsby PJ. A randomized controlled trial of intranasal ketamine in migraine with prolonged aura. Neurology. 2013 Feb 12;80(7):642-7. doi: 10.1212/WNL.0b013e3182824e66. Epub 2013 Jan 30.
- Results publication: PubMed 24127709Andolfatto G, Willman E, Joo D, Miller P, Wong WB, Koehn M, Dobson R, Angus E, Moadebi S. Intranasal ketamine for analgesia in the emergency department: a prospective observational series. Acad Emerg Med. 2013 Oct;20(10):1050-4. doi: 10.1111/acem.12229.
- Results publication: PubMed 24987995Del Pizzo J, Callahan JM. Intranasal medications in pediatric emergency medicine. Pediatr Emerg Care. 2014 Jul;30(7):496-501; quiz 502-4. doi: 10.1097/PEC.0000000000000171.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing intranasal ketamine, intranasal fentanyl and intranasal midazolam in people with Abscess and Pain, run by University of Tennessee at 1 site in United States.
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 1 inclusion and 9 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 27 Mar 2017. 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 United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in pain score measured utilizing the Faces Pain Scale-Revised (time frame: before medication administered and at 30 minutes after medication administration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02635282, which also lists 4 linked publications.
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 27 Mar 2017.