Oral Ketamine for Treatment of Vaso-Occlusive Pain

NCT05378555 | Recruiting Phase 3 FDA Drug

• 1 other identifier: IRB-P00038432
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to learn more about the feasibility of oral ketamine for the treatment of painful sickle-cell crises in children and adolescents as a supplement to intravenous (IV) opioids. There is a need for improved non-opioid analgesia for patients experiencing sickle-cell crises in the hospital and prehospital setting, as children and adolescents with sickle cell disease who experience sickle-cell crises often have severe pain that is not well controlled by high dose opioids, leading to poor pain management and opioid-related side effects. The study will begin when patients are admitted to the Emergency Department of Boston Children's Hospital for treatment of a sickle-cell crisis. Oral ketamine will be administered every 8 hours for the next 48 hours. Patients will have continuous cardiorespiratory monitoring for the duration of the study, as per routine care, as well as monitoring by the hospital's Acute Pain Service at least twice daily for pain management and side effects of pain treatment. At the end of the 48-hour study duration, patients will discuss with the Pain Service and Hematology Service whether to continue oral ketamine, change to intravenous ketamine, or discontinue ketamine based on clinical indications such as level of pain and sedation while on opioids.

Conditions

Vaso-occlusive Crisis

Keywords

Ketamine; Sickle-cell disease; Opioid-sparing; Analgesia

Outcome Measures

Primary Outcomes (1)

• Change in pain intensity scores using the Visual Analogue Scale (VAS) Pain Score Scale

  The Visual Analog Scale (VAS) will be used to measure pain. Scores are recorded on a line that represents a continuum between "no pain" and "worst pain."

  Baseline, and then every 4 hours for 48 hours

Secondary Outcomes (3)

• Change in Sedation Scores using modified Ramsey Sedation Scores Scale

  Baseline, and then every 4 hours for 48 hours

• Number of patients with abnormal vital signs

  Baseline, and then every 4 hours for 48 hours

• Frequency of side effects

  Baseline, and then every 4 hours for 48 hours

Study Arms (1)

Ketamine

EXPERIMENTAL

Drug: Ketamine Hydrochloride

Interventions

Ketamine Hydrochloride DRUG

All patients in this study will receive oral ketamine for the treatment of pain from vaso-occlusive crisis. Patients will receive 0.5 mg/kg ketamine Q8hrs for 48 hours.

Ketamine

Eligibility Criteria

• Age: 12 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients 12-24 years of age who require admission for vaso-occlusive pain

You may not qualify if:

• Patients who have had side effects to previous use of intravenous ketamine for treatment of vaso-occlusive pain that would preclude using ketamine for future pain episodes.
• Patient refusal to participate

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Related Publications (8)

• Ware RE, de Montalembert M, Tshilolo L, Abboud MR. Sickle cell disease. Lancet. 2017 Jul 15;390(10091):311-323. doi: 10.1016/S0140-6736(17)30193-9. Epub 2017 Feb 1.

  PMID: 28159390 BACKGROUND

• Neri C, Pestieau S, Young H, Elmi A, et al. Low-dose ketamine for children and adolescents with acute sickle cell disease related pain: a single center experience. J Anesth Clin Res 2014.

  BACKGROUND

• Telfer P, Kaya B. Optimizing the care model for an uncomplicated acute pain episode in sickle cell disease. Hematology Am Soc Hematol Educ Program. 2017 Dec 8;2017(1):525-533. doi: 10.1182/asheducation-2017.1.525.

  PMID: 29222301 BACKGROUND

• Lubega FA, DeSilva MS, Munube D, Nkwine R, Tumukunde J, Agaba PK, Nabukenya MT, Bulamba F, Luggya TS. Low dose ketamine versus morphine for acute severe vaso occlusive pain in children: a randomized controlled trial. Scand J Pain. 2018 Jan 26;18(1):19-27. doi: 10.1515/sjpain-2017-0140.

  PMID: 29794277 BACKGROUND

• Hagedorn JM, Monico EC. Ketamine Infusion for Pain Control in Acute Pediatric Sickle Cell Painful Crises. Pediatr Emerg Care. 2019 Jan;35(1):78-79. doi: 10.1097/PEC.0000000000000978.

  PMID: 27902670 BACKGROUND

• Bredlau AL, McDermott MP, Adams HR, Dworkin RH, Venuto C, Fisher SG, Dolan JG, Korones DN. Oral ketamine for children with chronic pain: a pilot phase 1 study. J Pediatr. 2013 Jul;163(1):194-200.e1. doi: 10.1016/j.jpeds.2012.12.077. Epub 2013 Feb 10.

  PMID: 23403253 BACKGROUND

• Fallon MT, Wilcock A, Kelly CA, Paul J, Lewsley LA, Norrie J, Laird BJA. Oral Ketamine vs Placebo in Patients With Cancer-Related Neuropathic Pain: A Randomized Clinical Trial. JAMA Oncol. 2018 Jun 1;4(6):870-872. doi: 10.1001/jamaoncol.2018.0131.

  PMID: 29621378 BACKGROUND

• Rosenblat JD, Carvalho AF, Li M, Lee Y, Subramanieapillai M, McIntyre RS. Oral Ketamine for Depression: A Systematic Review. J Clin Psychiatry. 2019 Apr 16;80(3):18r12475. doi: 10.4088/JCP.18r12475.

  PMID: 30995364 BACKGROUND

MeSH Terms

Conditions

Vaso-Occlusive Crises; Anemia, Sickle Cell; Agnosia

Interventions

Ketamine

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; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Central Study Contacts

Christine Greco, MD

CONTACT

857-218-3556; christine.greco@childrens.harvard.edu

Kimberly Lobo, MPH

CONTACT

857-218-3556; kimberly.lobo@childrens.harvard.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Division of Pain Medicine

Model Details: All patients in this study will receive oral ketamine for the treatment of pain from vaso-occlusive crisis.

Study Record Dates

• First Submitted: April 6, 2022
• First Posted: May 18, 2022
• Study Start: May 1, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: November 21, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)