Low-dose Ketamine vs Morphine for Vaso-occlusive Crisis in Sicklers

NCT02434939 | Completed Phase 4 Results DMC

• 1 other identifier: 2013/HD07/606U
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial will inform of the role of Low dose ketamine in the acute treatment of severe painful sickle cell crisis in children in a day-case sickle cell centre. The primary aim is to determine whether Low dose ketamine is non inferior to morphine in the management of acute painful sickle cell crises. The specific objectives will be to determine the maximal change in NRS pain score following administration of ketamine and to examine the safety profile of ketamine compared to morphine in this population. The investigators hypothesize that low dose ketamine will result in similar effective pain control as morphine alone and will not be associated with an increase in adverse events.

Conditions

Sickle Cell Crisis; Acute Pain

Outcome Measures

Primary Outcomes (1)

• Maximal Change in NRS Pain Scores as a Percentage of Baseline NRS Pain Score.

  Our primary outcome measurement was the maximum change on the verbal NRS pain scale compared with their initial score (baseline). The NRS was used to measure a patient's subjective level of pain on a scale from 0 (representing no pain at all) to 10 (the worst pain imaginable) using whole numbers. The NRS score was documented just prior to the administration of the study drug (time zero). After infusion of the study drug was complete, NRS scores were documented at 5, 10, 20, and then every 20 minutes thereafter up to 120 minutes. We stopped recording NRS scores prior to 120 minutes if the patient requested a third dose of the study drug, withdrew consent or developed a severe adverse effect.

  5, 10, 20,25,30, 40,45,50 60, 80, 100, 120 minutes post drug adminstration

Secondary Outcomes (3)

• Time to Maximal Analgesic Effect and Duration of Action of Ketamine

  5, 10, 20, 40, 60, 80, 100, 120 minutes post drug administration

• Incidence of Side Effects, Including Outlying Vital Signs

  5, 10, 20, 40, 60, 80, 100, 120 minutes post drug administration

• Incidence of Treatment Failure by Treatment Group.

  120 minutes

Study Arms (2)

Low dose ketamine

EXPERIMENTAL

Low dose ketamine 1mg/kg given as an IV infusion via syringe pump over 10 minutes. Maximum of 2 doses to be given during study period that will last 2 hours.

Drug: Low dose ketamine

Morphine

ACTIVE COMPARATOR

Morphine 0.1mg/kg given as an IV infusion via a syringe pump over 10 minutes. Maximum of 2 doses to be given during the study period that will last 2 hours.

Drug: Morphine

Interventions

Low dose ketamine DRUG

Children in this arm shall receive a slow infusion of ketamine at a sub-anesthetic dose and monitored for pain, vital signs and side effects for 2 hours. Records will be taken at 5, 10, 20, 40, 60, 80, 100 and 120min.

Also known as: Ketamine hydrochrolide 50mg/ml,Nirma Pharmaceuticals (India)

Low dose ketamine

Morphine DRUG

Children in this arm shall receive intravenous infusion of morphine at analgesic dose and then monitored for pain, vital signs and side effects for 2 hours. Records will be taken at 5, 10, 20, 40, 60, 80, 100 and 120min.

Also known as: Morphine sulphate 10mg/ml, Martindale Pharmaceuticals (UK)

Morphine

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Children aged 7-18 years
• sickle cell anemia patient with severe acute painful crisis
• Parental consent and child assent where applicable

You may not qualify if:

• Oxygen saturations below 90% on initial assessment
• Altered conscious and mental state that hinders communication
• Current enrollment in another clinical trial involving an investigational drug.
• History of a stroke
• Hypertension,
• Increased intracranial pressure.
• Glaucoma,
• Failed/ Difficult IV access

Sponsors & Collaborators

• Makerere University: lead

Study Sites (1)

Sickle Cell clinic, Mulago Hospital Complex

Kampala, 256, Uganda

Location

Related Publications (2)

• Marcus RJ, Victoria BA, Rushman SC, Thompson JP. Comparison of ketamine and morphine for analgesia after tonsillectomy in children. Br J Anaesth. 2000 Jun;84(6):739-42. doi: 10.1093/oxfordjournals.bja.a013585.

  PMID: 10895748 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 DERIVED

MeSH Terms

Conditions

Vaso-Occlusive Crises; Acute Pain

Interventions

Ketamine; Morphine

Condition Hierarchy (Ancestors)

Anemia, Sickle Cell; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Limitations and Caveats

single centre trial could limit generizability, ketamine specific side effects (nystagmus) led to potential unblinding and NRS and RSS not validated for use

Results Point of Contact

• Title: Dr.Lubega Felix Anthony
• Organization: Makerere University ,College of Health Sciences, Department of Anesthesia and Critical care

falubega@chs.mak.ac.ug

+256777756571

Study Officials

• Felix A. Lubega, MBChB

  Makerere University, College of Health Sciences, Department of Anesthesia and Critical Care

  PRINCIPAL INVESTIGATOR

• Tonny S. Luggya, MMed

  Makerere University, College of Health Sciences, Department of Anaesthesia and Critical care

  STUDY CHAIR

• Deogratias Munube, MMed

  Makerere University, College of Health Sciences, Department of Child Health and Pediatrics

  STUDY DIRECTOR

• Fred Bulamba, MBChB

  Makerere University, College of Health Sciences, Department of Anaesthesia and Critical care

  STUDY DIRECTOR

• Mithrika S De Silva, MD

  University of Sydney, Department of Peadiatrics

  STUDY DIRECTOR

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

Study Record Dates

• First Submitted: April 22, 2015
• First Posted: May 6, 2015
• Study Start: June 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: February 1, 2016
• Last Updated: August 3, 2016
• Results First Posted: August 3, 2016

Record last verified: 2016-06

Locations

UG (1)