Sub-dissociative Intranasal Ketamine for Pediatric Sickle Cell Pain Crises

March 12, 2019 updated by: Cameroon Baptist Convention Health

Comparison of Sub-dissociative Intranasal Ketamine Plus Standard Pain Therapy Versus Standard Pain Therapy in the Treatment of Pediatric Sickle Cell Disease Vasoocclusive Crises in Resource-limited Settings: a Multi-centered, Randomized, Controlled Trial

The purpose of this study is to determine if the use of ketamine, sniffed in the nose, is a safe and effective way to help reduce pain in pediatric sickle cell patients with pain crises in resource-limited settings.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This is a randomized, placebo-controlled, drug trial using sub-dissociative intranasal ketamine as an adjunct to standard pharmacotherapy for the management of pediatric sickle cell disease vasoocclusive pain crises in resource-poor settings. Pediatric patients will be enrolled at a teaching and referral hospital in West Africa. Patients will be randomly assigned to the treatment arm - standard therapy plus sub-dissociative intranasal ketamine (1 mg/kg) given at time zero) or the control arm - standard therapy plus intranasal normal saline (volume-matched to treatment arm), and patients will evaluated at standard intervals to assess for pain scores and vital signs (0 minutes, 30 minutes, 60 minutes, and 120 minutes). Pain will be assessed using the Faces Pain Scale - Revised (FPS-R). Patients will also be observed for any potential side effects or adverse events. All patients will be contacted 2-3 weeks post intranasal medication administration for over-the-phone follow-up using a portion of the PedsQL-SCD questionnaire, to assess for basic quality of life related to pain management and treatment.

Study Type

Interventional

Enrollment (Anticipated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Cameroon
    • Northwest Province
      • Bamenda, Northwest Province, Cameroon
        • Recruiting
        • Mbingo Baptist Hospital
        • Contact:
        • Contact:
          • Ernest Nshom, MD
        • Sub-Investigator:
          • Ethan Helm, MD
        • Principal Investigator:
          • Ernest Nshom, MD
  • Tanzania
      • Dar es Salam, Tanzania
        • Not yet recruiting
        • Muhimbili National Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hendry R Sawe, MD
        • Sub-Investigator:
          • Juma Mfinanga, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 16 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Sickle cell disease (SCD)
  • Vasoocclusive pain crisis
  • Requiring analgesia

Exclusion Criteria:

  • Anatomic variations of nose precluding intranasal medication administration
  • Ketamine allergy
  • Non-verbal
  • Obtunded
  • Pregnant

  • Other acute SCD complications:

    • Acute chest syndrome
    • Sepsis
    • Stroke
    • Splenic sequestration
    • Pulmonary embolism
    • Acute osteomyelitis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intranasal Ketamine
Patients allocated to receive intranasal ketamine (intervention) in addition to standard pain therapy. Patients enrolled in this arm will utilize the FPS-R and follow-up PedsQL-SCD.
Drug: Ketamine
Intranasal ketamine (concentration: 50 mg/ml, dose: 1 mg/kg) will be given at time zero. Intranasal administration will be performed by placing the needleless syringe gently into the nares with the patient sitting upright. Volumes of ≤ 0.75ml will be nasally inhaled in a single nare, while volumes > 0.75ml will be divided between both nares. Patients who are unable to inhale the medication nasally will receive drip administration of the same volume while recumbent on the bed.
Other: Standard Pain Therapy
Typical management strategy for pediatric sickle cell disease vasoocclusive crises including acetaminophen/paracetamol, ibuprofen, oral opioids, and injectable opioids depending on pain severity.
Other: Pediatric Quality of Life - Sickle Cell Disease Module
Standardized quality of life assessment performed 2-3 weeks post intranasal medication administration to evaluate pain management and severity of symptoms after discharge from the hospital.
Other Names:
  • PedsQL-SCD
Other: Faces Pain Scale - Revised
All patients will answer the FPS-R at 0 minutes (immediately prior to receiving intranasal medication), 30 minutes, 60 minutes, and 120 minutes to assess current pain status.
Other Names:
  • FPS-R
Placebo Comparator: Normal Saline
Patients allocated to receive intranasal normal saline (placebo) in addition to standard pain therapy. Patients enrolled in this arm will utilize the FPS-R and follow-up PedsQL-SCD.
Other: Standard Pain Therapy
Typical management strategy for pediatric sickle cell disease vasoocclusive crises including acetaminophen/paracetamol, ibuprofen, oral opioids, and injectable opioids depending on pain severity.
Other: Pediatric Quality of Life - Sickle Cell Disease Module
Standardized quality of life assessment performed 2-3 weeks post intranasal medication administration to evaluate pain management and severity of symptoms after discharge from the hospital.
Other Names:
  • PedsQL-SCD
Other: Faces Pain Scale - Revised
All patients will answer the FPS-R at 0 minutes (immediately prior to receiving intranasal medication), 30 minutes, 60 minutes, and 120 minutes to assess current pain status.
Other Names:
  • FPS-R
Drug: Normal Saline
Intranasal normal saline (placebo: volume-matched with intranasal ketamine) will be given at time zero. Intranasal administration will be performed by placing the needleless syringe gently into the nares with the patient sitting upright. Volumes of ≤ 0.75ml will be nasally inhaled in a single nare, while volumes > 0.75ml will be divided between both nares. Patients who are unable to inhale the medication nasally will receive drip administration of the same volume while recumbent on the bed.
Other Names:
  • NaCl 0.9%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline (time zero) in FPS-R scores between treatment groups
Time Frame: Baseline (time zero, indicated by injection of intranasal medication), 30 minutes, 60 minutes, and 120 minutes
Measure of differences of change of FPS-R scores from baseline to 30 minutes, 60 minutes, and 120 minutes compared between treatment arms
Baseline (time zero, indicated by injection of intranasal medication), 30 minutes, 60 minutes, and 120 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital length of stay
Time Frame: through study completion, an average of 3 days
Hospital length of stay recorded from time zero to time of discharge documented by the study clinician will be a secondary outcome measure.
through study completion, an average of 3 days
Quality of life assessment (PedsQL-SCD Module scores)
Time Frame: Time of first intranasal administration to 3 weeks post intranasal intervention.
PedsQL-SCD Module scores obtained by study clinicians using over-the-phone interviews between two-three weeks post intervention will be a secondary outcome measure.
Time of first intranasal administration to 3 weeks post intranasal intervention.
Analgesia use - paracetamol
Time Frame: Time of initial intranasal drug administration to 2 hours post intranasal drug administration
Individual evaluation of total paracetamol use per kilogram body weight
Time of initial intranasal drug administration to 2 hours post intranasal drug administration
Analgesia use - ibuprofen
Time Frame: Time of initial intranasal drug administration to 2 hours post intranasal drug administration
Individual evaluation of total ibuprofen use per kilogram body weight
Time of initial intranasal drug administration to 2 hours post intranasal drug administration
Analgesia use - opioids
Time Frame: Time of initial intranasal drug administration to 2 hours post intranasal drug administration
Individual evaluation of total opioid use expressed as morphine equivalents per body weight.
Time of initial intranasal drug administration to 2 hours post intranasal drug administration

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events
Time Frame: Time of initial intranasal drug administration to 2 hours post intranasal drug administration
Adverse events include: bad taste is mouth, drowsiness, dizziness, itchy nose, nausea, dysphoria, and other novel subjective negative experiences
Time of initial intranasal drug administration to 2 hours post intranasal drug administration
Serious Adverse Events
Time Frame: Time of initial intranasal drug administration to 2 hours post intranasal drug administration
Serious adverse events include: apnea, assisted ventilation, bradypnea, cyanosis, dissociation, emergence reaction, hypotension, laryngospasm, myoclonus, seizure, and vomiting
Time of initial intranasal drug administration to 2 hours post intranasal drug administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cameroon Baptist Convention Health

Collaborators

Carolinas Medical Center
Muhimbili National Hospital

Investigators

  • Study Director: Ernest Nshom, MD, Cameroon Baptist Convention Health
  • Study Chair: Michael Runyon, MD, Carolinas Medical Center
  • Study Director: Stacy Reynolds, MD, Carolinas Medical Center
  • Study Director: Hendry R Sawe, MD, Muhimbili University of Health and Allied Sciences
  • Study Director: Juma Mfinanga, MD, Mihumbili National Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Anticipated)

July 1, 2019

Study Completion (Anticipated)

July 1, 2019

Study Registration Dates

First Submitted

October 8, 2015

First Submitted That Met QC Criteria

October 9, 2015

First Posted (Estimate)

October 12, 2015

Study Record Updates

Last Update Posted (Actual)

March 14, 2019

Last Update Submitted That Met QC Criteria

March 12, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB2015-07
  • MNH/IRB/I/2015/14 (Other Identifier: Muhimbili National Hospital IRB)
  • TFDA0015/CTR/0015/9 (Other Identifier: Tanzania Food and Drugs Authority)
  • NIMR/HQ/R.8a/Vol. IX/2299 (Other Identifier: Tanzania National Institute for Medical Research)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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