NCT02388321

Brief Summary

Direct comparison of intranasal sub-dissociative dose ketamine with intranasal fentanyl for the treatment of moderate to severe pain in pediatric patients in the emergency department.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for phase_4 pain

Timeline
Completed

Started May 2015

Typical duration for phase_4 pain

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 9, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 17, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 14, 2017

Completed
7 months until next milestone

Results Posted

Study results publicly available

May 8, 2018

Completed
Last Updated

May 8, 2018

Status Verified

October 1, 2017

Enrollment Period

1.7 years

First QC Date

February 9, 2015

Results QC Date

March 26, 2018

Last Update Submit

May 7, 2018

Conditions

Pain

Keywords

Analgesiapediatricspain management

Outcome Measures

Primary Outcomes (1)

  • Pain Score at 30 Minutes

    An 11 point Likert Visual Analog Scale with 0 being no pain, 5 being moderate pain and 10 being very severe pain was verbally administered to the patient at 30 minutes post administration of analgesia.

    30 minutes

Secondary Outcomes (1)

  • Adverse Events at 30 Minutes

    30 minutes

Study Arms (2)

Ketamine

EXPERIMENTAL

intranasal sub-dissociative dose ketamine for the treatment of moderate to severe pain in pediatric patients in the emergency department.

Drug: Ketamine

Fentanyl

ACTIVE COMPARATOR

intranasal fentanyl for the treatment of moderate to severe pain in pediatric patients in the emergency department.

Drug: Fentanyl

Interventions

KetamineDRUG

intranasal sub-dissociative dose ketamine for the treatment of moderate to severe pain in pediatric patients in the emergency department.

Ketamine
FentanylDRUG

intranasal fentanyl for the treatment of moderate to severe pain in pediatric patients in the emergency department.

Also known as: Fetanyl
Fentanyl

Eligibility Criteria

Age3 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children aged 3-17,
  • weighing less than 50kg
  • present to the pediatric ED with moderate-severe acute pain (defined as pain greater than or equal to 6/10).
  • Treating physician determines the patient to require opioid analgesia.

You may not qualify if:

  • Children with facial trauma or any abnormal nasal anatomy;
  • developmentally delayed children;
  • children with head trauma/increased intracranial pressure (ICP);
  • children with known allergy to fentanyl or ketamine;
  • children who are unable to provide pain scale assessment;
  • children with chronic pain of greater than 4 weeks;
  • Pregnant females;
  • and children with a Glasgow Coma Scale (GCS)\<15.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maimonides Medical Center

Brooklyn, New York, 11219, United States

Location

Related Publications (17)

  • Andolfatto 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.

    PMID: 24127709BACKGROUND

  • Borland M, Jacobs I, King B, O'Brien D. A randomized controlled trial comparing intranasal fentanyl to intravenous morphine for managing acute pain in children in the emergency department. Ann Emerg Med. 2007 Mar;49(3):335-40. doi: 10.1016/j.annemergmed.2006.06.016. Epub 2006 Oct 25.

    PMID: 17067720BACKGROUND

  • Borland ML, Clark LJ, Esson A. Comparative review of the clinical use of intranasal fentanyl versus morphine in a paediatric emergency department. Emerg Med Australas. 2008 Dec;20(6):515-20. doi: 10.1111/j.1742-6723.2008.01138.x.

    PMID: 19125831BACKGROUND

  • Borland M, Milsom S, Esson A. Equivalency of two concentrations of fentanyl administered by the intranasal route for acute analgesia in children in a paediatric emergency department: a randomized controlled trial. Emerg Med Australas. 2011 Apr;23(2):202-8. doi: 10.1111/j.1742-6723.2011.01391.x. Epub 2011 Feb 8.

    PMID: 21489168BACKGROUND

  • Garra G, Singer AJ, Taira BR, Chohan J, Cardoz H, Chisena E, Thode HC Jr. Validation of the Wong-Baker FACES Pain Rating Scale in pediatric emergency department patients. Acad Emerg Med. 2010 Jan;17(1):50-4. doi: 10.1111/j.1553-2712.2009.00620.x. Epub 2009 Dec 9.

    PMID: 20003121BACKGROUND

  • Goldman RD: Intranasal drug delivery for children with acute illness. Curr Drug Ther 2006, 1(1):127-130.

    BACKGROUND

  • Grassin-Delyle S, Buenestado A, Naline E, Faisy C, Blouquit-Laye S, Couderc LJ, Le Guen M, Fischler M, Devillier P. Intranasal drug delivery: an efficient and non-invasive route for systemic administration: focus on opioids. Pharmacol Ther. 2012 Jun;134(3):366-79. doi: 10.1016/j.pharmthera.2012.03.003. Epub 2012 Mar 23.

    PMID: 22465159BACKGROUND

  • Graudins A, Meek R, Egerton-Warburton D, Seith R, Furness T, Chapman R. The PICHFORK (Pain InCHildren Fentanyl OR Ketamine) trial comparing the efficacy of intranasal ketamine and fentanyl in the relief of moderate to severe pain in children with limb injuries: study protocol for a randomized controlled trial. Trials. 2013 Jul 10;14:208. doi: 10.1186/1745-6215-14-208.

    PMID: 23842536BACKGROUND

  • Holdgate A, Cao A, Lo KM. The implementation of intranasal fentanyl for children in a mixed adult and pediatric emergency department reduces time to analgesic administration. Acad Emerg Med. 2010 Feb;17(2):214-7. doi: 10.1111/j.1553-2712.2009.00636.x.

    PMID: 20070272BACKGROUND

  • Karlsen AP, Pedersen DM, Trautner S, Dahl JB, Hansen MS. Safety of intranasal fentanyl in the out-of-hospital setting: a prospective observational study. Ann Emerg Med. 2014 Jun;63(6):699-703. doi: 10.1016/j.annemergmed.2013.10.025. Epub 2013 Nov 22.

    PMID: 24268523BACKGROUND

  • Miner JR, Kletti C, Herold M, Hubbard D, Biros MH. Randomized clinical trial of nebulized fentanyl citrate versus i.v. fentanyl citrate in children presenting to the emergency department with acute pain. Acad Emerg Med. 2007 Oct;14(10):895-8. doi: 10.1197/j.aem.2007.06.036.

    PMID: 17898251BACKGROUND

  • National Institute of Clinical Studies: Emergency care acute pain management manual, National Health and Medical Research Council. Canberra, Australia: ACT; 2011.

    BACKGROUND

  • Page MG, Katz J, Stinson J, Isaac L, Martin-Pichora AL, Campbell F. Validation of the numerical rating scale for pain intensity and unpleasantness in pediatric acute postoperative pain: sensitivity to change over time. J Pain. 2012 Apr;13(4):359-69. doi: 10.1016/j.jpain.2011.12.010. Epub 2012 Mar 15.

    PMID: 22424915BACKGROUND

  • Rickard C, O'Meara P, McGrail M, Garner D, McLean A, Le Lievre P. A randomized controlled trial of intranasal fentanyl vs intravenous morphine for analgesia in the prehospital setting. Am J Emerg Med. 2007 Oct;25(8):911-7. doi: 10.1016/j.ajem.2007.02.027.

    PMID: 17920976BACKGROUND

  • Saunders M, Adelgais K, Nelson D. Use of intranasal fentanyl for the relief of pediatric orthopedic trauma pain. Acad Emerg Med. 2010 Nov;17(11):1155-61. doi: 10.1111/j.1553-2712.2010.00905.x.

    PMID: 21175512BACKGROUND

  • Yeaman F, Meek R, Egerton-Warburton D, Rosengarten P, Graudins A. Sub-dissociative-dose intranasal ketamine for moderate to severe pain in adult emergency department patients. Emerg Med Australas. 2014 Jun;26(3):237-42. doi: 10.1111/1742-6723.12173. Epub 2014 Apr 8.

    PMID: 24712757BACKGROUND

  • Yeaman F, Oakley E, Meek R, Graudins A. Sub-dissociative dose intranasal ketamine for limb injury pain in children in the emergency department: a pilot study. Emerg Med Australas. 2013 Apr;25(2):161-7. doi: 10.1111/1742-6723.12059. Epub 2013 Mar 20.

    PMID: 23560967BACKGROUND

MeSH Terms

Conditions

PainAgnosia

Interventions

KetamineFentanyl

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Limitations and Caveats

Small Sample size

Results Point of Contact

Title
Sergey Motov, MD (Prinicipal Investigator)
Organization
Maimonides Medical Center
smotov@maimonidesmed.org
718-283-8693

Study Officials

  • Sabina Zavolkovskaya, MD

    Maimonides Medical Center

    PRINCIPAL INVESTIGATOR

  • Sergey Motov, MD

    Maimonides Medical Center

    STUDY DIRECTOR

  • John Marshall, MD

    Maimonides Medical Center

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Manager

Study Record Dates

First Submitted

February 9, 2015

First Posted

March 17, 2015

Study Start

May 1, 2015

Primary Completion

December 31, 2016

Study Completion

October 14, 2017

Last Updated

May 8, 2018

Results First Posted

May 8, 2018

Record last verified: 2017-10

Locations

US(1)