Ketamine Infusion for Acute Sickle Cell Crisis in the Emergency Department

NCT02417298 | Terminated

• 1 other identifier: 668842
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Pain associated with sickle cell disease is a common emergency department visit. It is also frequently associated with a high emergency department recidivism rate for pain control and admissions to the hospital. Opiates are considered the first line therapy for acute flares and to manage chronic pain. This often times leads to a stigma of being "opiate seekers" or "frequent fliers". With this study, we wish to explore whether adding ketamine to standard acute opiate therapy (morphine or dilaudid) will decrease subsequent repeat doses of opiates while improving the patient's perception of pain. In addition, we will be exploring whether ketamine as an adjuvant therapy can help reduce hospital admissions for the management of acute sickle cell crisis pain.

Conditions

Pain; Sickle Cell Disorder

Keywords

ketamine; pain; sickle cell disorder

Outcome Measures

Primary Outcomes (2)

• Change in patient's perception of pain

  Pain will be assessed via the Numeric Rated Scale (NRS)

  At baseline, 30, 60, 90, 120, 150 and 180 min after administration of intervention

• Total number of patients requiring hospital admission

  At the end of the study (180 minutes after initial administration of intervention) the number of patients requiring hospital admission will be quantified

  180 min after administration of intervention

Secondary Outcomes (11)

• Change in patient perception of pain after discharge

  24 and 72 hours post ED discharge

• Total opiate consumed

  0, 30, 60, 90, 120, 150, and 180 minutes after administration of study intervention

• Post test of disability and functional outcomes using the Sickle Cell Pain Burden Interview (SCPBI)

  180 minutes after initial study intervention

• Incidence of hypertension

  0, 30, 60, 90, 120, 150, and 180 minutes after administration of study intervention

• Incidence of dissociative effects (characterized by hallucination, disorientation, confusion, agitation, delirium, dreams)

  0, 30, 60, 90, 120, 150, and 180 minutes after administration of study intervention

Study Arms (2)

Ketamine

ACTIVE COMPARATOR

Ketamine 0.3 mg/kg intravenous push followed by ketamine infusion at 0.1 mg/kg/hr for 3 hours

Drug: Ketamine

Saline

PLACEBO COMPARATOR

Normal saline intravenous push (with volume to be administered equivalent to that of ketamine 0.3mg/kg, if the patient was to receive ketamine) followed by a normal saline infusion at the same rate as ketamine arm

Drug: Normal saline

Interventions

Normal saline DRUG

Normal saline intravenous push (with volume to be administered equivalent to that of ketamine 0.3mg/kg, if the patient was to receive ketamine) followed by a normal saline infusion at the same rate as ketamine arm

Saline

Ketamine DRUG

0.3mg/kg IVP ketamine followed by 0.1mg/kg/hr of ketamine infusion for 3 hours

Ketamine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients 18 years old and older presenting with acute sickle cell crisis pain either described as diffuse throughout the body or localized to joint/extremity/back
• Describes pain to be greater than or equal to 2 on the NRS
• Consents to IV access
• Provides informed consent

You may not qualify if:

• Receiving IM therapy only
• Standard therapy plan is not morphine or dilaudid
• Previous enrollment in study
• Documented fever or subjectively reported fever
• Complaint of chest pain or shortness of breath or abdominal pain or headache
• Suspicion for acute chest crisis
• Patients with history or acute diagnosis of subarachnoid hemorrhage/increased intracranial pressure
• Severe hypertension(≥180/100)
• History of CAD or hypertension
• Presence of/suspected for traumatic head injury with or without loss of consciousness
• Presence of/suspected for myocardial ischemia
• Presence of/suspected for alcohol intoxication
• Hemodynamic instability
• History of psychiatric disorders,
• Known or suspected pregnancy or breastfeeding

Sponsors & Collaborators

• Billy Sin: lead

Study Sites (1)

The Brooklyn Hospital Center

Brooklyn, New York, 11201, United States

Location

Related Publications (7)

• Neri CM, Pestieau SR, Darbari DS. Low-dose ketamine as a potential adjuvant therapy for painful vaso-occlusive crises in sickle cell disease. Paediatr Anaesth. 2013 Aug;23(8):684-9. doi: 10.1111/pan.12172. Epub 2013 Apr 9.

  PMID: 23565738 BACKGROUND

• Jennings CA, Bobb BT, Noreika DM, Coyne PJ. Oral ketamine for sickle cell crisis pain refractory to opioids. J Pain Palliat Care Pharmacother. 2013 Jun;27(2):150-4. doi: 10.3109/15360288.2013.788599. Epub 2013 May 21.

  PMID: 23692261 BACKGROUND

• Tawfic QA, Faris AS, Kausalya R. The role of a low-dose ketamine-midazolam regimen in the management of severe painful crisis in patients with sickle cell disease. J Pain Symptom Manage. 2014 Feb;47(2):334-40. doi: 10.1016/j.jpainsymman.2013.03.012. Epub 2013 Jul 12.

  PMID: 23856095 BACKGROUND

• Zempsky WT, Loiselle KA, Corsi JM, Hagstrom JN. Use of low-dose ketamine infusion for pediatric patients with sickle cell disease-related pain: a case series. Clin J Pain. 2010 Feb;26(2):163-7. doi: 10.1097/AJP.0b013e3181b511ab.

  PMID: 20090444 BACKGROUND

• Meals CG, Mullican BD, Shaffer CM, Dangerfield PF, Ramirez RP. Ketamine infusion for sickle cell crisis pain in an adult. J Pain Symptom Manage. 2011 Sep;42(3):e7-9. doi: 10.1016/j.jpainsymman.2011.06.003. No abstract available.

  PMID: 21854993 BACKGROUND

• Uprety D, Baber A, Foy M. Ketamine infusion for sickle cell pain crisis refractory to opioids: a case report and review of literature. Ann Hematol. 2014 May;93(5):769-71. doi: 10.1007/s00277-013-1954-3. Epub 2013 Nov 15.

  PMID: 24232306 BACKGROUND

• Yawn BP, Buchanan GR, Afenyi-Annan AN, Ballas SK, Hassell KL, James AH, Jordan L, Lanzkron SM, Lottenberg R, Savage WJ, Tanabe PJ, Ware RE, Murad MH, Goldsmith JC, Ortiz E, Fulwood R, Horton A, John-Sowah J. Management of sickle cell disease: summary of the 2014 evidence-based report by expert panel members. JAMA. 2014 Sep 10;312(10):1033-48. doi: 10.1001/jama.2014.10517.

  PMID: 25203083 BACKGROUND

MeSH Terms

Conditions

Pain; Anemia, Sickle Cell

Interventions

Saline Solution; Ketamine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; 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)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Michael Hochberg, MD

  The Brooklyn Hospital Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Primary investigator

Study Record Dates

• First Submitted: March 25, 2015
• First Posted: April 15, 2015
• Study Start: November 1, 2015
• Primary Completion: April 1, 2018
• Study Completion: May 1, 2018
• Last Updated: May 11, 2018

Record last verified: 2018-05

Locations

US (1)