Sub-dissociative Intranasal Ketamine for Pediatric Sickle Cell Pain Crises

NCT02573714 | Unknown DMC

• 4 other identifiers: IRB2015-07MNH/IRB/I/2015/14TFDA0015/CTR/0015/9NIMR/HQ/R.8a/Vol. IX/2299
• Study Type: interventional
• Target: 160
• Locations: 2 countries
• Sites: 2

Brief Summary

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.

Conditions

Sickle Cell Disease

Keywords

Ketamine; Intranasal; Pain crisis; Vasoocclusive Pain; Sickle cell disease

Outcome Measures

Primary Outcomes (1)

• Change from Baseline (time zero) in FPS-R scores between treatment groups

  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 Outcomes (5)

• Hospital length of stay

  through study completion, an average of 3 days

• Quality of life assessment (PedsQL-SCD Module scores)

  Time of first intranasal administration to 3 weeks post intranasal intervention.

• Analgesia use - paracetamol

  Time of initial intranasal drug administration to 2 hours post intranasal drug administration

• Analgesia use - ibuprofen

  Time of initial intranasal drug administration to 2 hours post intranasal drug administration

• Analgesia use - opioids

  Time of initial intranasal drug administration to 2 hours post intranasal drug administration

Other Outcomes (2)

• Adverse Events

  Time of initial intranasal drug administration to 2 hours post intranasal drug administration

• Serious Adverse Events

  Time of initial intranasal drug administration to 2 hours post intranasal drug administration

Study Arms (2)

Intranasal Ketamine

EXPERIMENTAL

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; Other: Standard Pain Therapy; Other: Pediatric Quality of Life - Sickle Cell Disease Module; Other: Faces Pain Scale - Revised

Normal Saline

PLACEBO COMPARATOR

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.

Drug: Normal Saline; Other: Standard Pain Therapy; Other: Pediatric Quality of Life - Sickle Cell Disease Module; Other: Faces Pain Scale - Revised

Interventions

Ketamine DRUG

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.

Intranasal Ketamine

Normal Saline DRUG

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.

Also known as: NaCl 0.9%

Normal Saline

Standard Pain Therapy OTHER

Typical management strategy for pediatric sickle cell disease vasoocclusive crises including acetaminophen/paracetamol, ibuprofen, oral opioids, and injectable opioids depending on pain severity.

Intranasal Ketamine; Normal Saline

Pediatric Quality of Life - Sickle Cell Disease Module OTHER

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.

Also known as: PedsQL-SCD

Intranasal Ketamine; Normal Saline

Faces Pain Scale - Revised OTHER

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.

Also known as: FPS-R

Intranasal Ketamine; Normal Saline

Eligibility Criteria

• Age: 4 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cameroon Baptist Convention Health: lead
• Carolinas Medical Center: collaborator
• Muhimbili National Hospital: collaborator

Study Sites (2)

Mbingo Baptist Hospital

Bamenda, Northwest Province, Cameroon

RECRUITING

Muhimbili National Hospital

Dar es Salaam, Tanzania

NOT YET RECRUITING

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MeSH Terms

Conditions

Anemia, Sickle Cell

Interventions

Ketamine; Saline Solution; Sodium Chloride

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Ernest Nshom, MD

  Cameroon Baptist Convention Health

  STUDY DIRECTOR

• Michael Runyon, MD

  Carolinas Medical Center

  STUDY CHAIR

• James R Young, MD

  Carolinas Medical Center

  PRINCIPAL INVESTIGATOR

• 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

  STUDY DIRECTOR

Central Study Contacts

James R Young, MD

CONTACT

704-578-5078; james.young@carolinashealthcare.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2015
• First Posted: October 12, 2015
• Study Start: December 1, 2015
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: March 14, 2019

Record last verified: 2019-03

Locations

CA (1); TA (1)