Pain
Conditions
Keywords
pain management, ketamine, morphine, pediatrics, emergency medicine
Brief summary
The proposed trial is a prospective, double blinded, randomized control trial with the primary aim of determining whether a single, sub-dissociative dose of ketamine will decrease the total narcotic requirements of pediatric patients requiring intravenous analgesia in an urban emergency department (ED) compared to a group of patients who receive morphine alone for pain management. Patients are randomized to receive either a single bolus of ketamine (0.3 mg/kg) or a single bolus of morphine (0.05mg/kg). All subsequent pain management will be accomplished using morphine. Patient, family member, and research staff pain scores will be recorded, until 3 hours post study medication administration. Family members are contacted via telephone 24 hours post-ED discharge, and again at 7 days post-hospital discharge, for evaluation via Post Hospitalization Behavior Questionnaire. Narcotic equivalents will be calculated for up to 3 hours post study medication administration and compared between the ketamine and morphine groups.
Interventions
DRUGKetamine
DRUGMorphine
Sponsors
HealthPartners Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Age: 3-17 years old * Condition (medical or trauma) requiring opioid pain management per standard of care * Need to establish an IV per standard of care * Treating physician agrees to manage the patient's pain with morphine following randomization.
Exclusion criteria
* Trauma Team Activation * Known allergy to ketamine * Family member unable/unavailable to provide informed consent * When appropriate, patient unwilling to provide assent * High suspicion of injury related to child abuse * Patient and/or family member is non-English speaking * Patient is incarcerated
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative Narcotic Consumption | 3 hours post study drug administration | All opioids administered were converted to morphine equivalents in milligrams (eq. mg) via standard equianalgesic calculations. Pre-study drug opioids information was also collected.The number of subjects who received a morphine dose after administration of the study drug, both within one hour or at all was included in the outcome measure results. |
| Adverse Drug Reaction | 3 hours post study drug administration | Rate of pain medication related adverse events during their ED stay and at 24 hours post discharge from the ED. the research team will complete the Adverse Event case report form to determine any adverse events occurring during the study period. Family members will be contacted via telephone 24 hours (±8 hours) following their visit in the Emergency Department to complete the Discharge Adverse Event case report form. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Pain Scale Rating Agreement Among Patient, Parent, and Research Staff | Up to 3 hours post pain medication administration | FLACC scores were assessed on the patient using the FLACC scale (0-10) by the parent, treating RN/trained research assistant. * FLACC - Parents 30 Minutes Post dose * FLACC - Staff 30 Minutes Post dose Wong-Baker Faces scale is a self-assessment of pain Scale of 1-10 pain. |
Countries
United States
Participant flow
Pre-assignment details
77 met eligibility criteria and 63 were randomized to one of the two study groups.
Participants by arm
| Arm | Count |
|---|---|
| Ketamine Ketamine, single dose, 0.3 mg/kg, IV
The final sample included 40 subjects, 20 in the Ketamine group. Inclusion criteria was defined as, patients age 3-17 years old, medical or traumatic condition requiring intravenous opioid analgesics, ability to obtain consent from parents and assent from the patient. The baseline characteristics were similar between the two groups. These patients were randomized to receive a single bolus of ketamine (0.3 mg/kg). These are standard recommended pediatric weight-based analgesic doses of Ketamine. Patient weight was obtained by the treating RN using a scale or Broselow tape. A blinded 10mL syringe containing study drug was prepared and delivered to the bedside by a pharmacist. After administration of study drug all future analgesic doses were restricted to morphine and were given at the discretion of the treatment team. | 31 |
| Morphine Morphine, single dose, 0.05 mg/kg, IV
The final sample included 40 subjects, 20 in the Morphine group. The baseline characteristics were similar between the two groups. These patients were randomized to receive a single bolus of morphine (0.05mg/kg). These are standard recommended pediatric weight-based analgesic doses of Morphine. Patient weight was obtained by the treating RN using a scale or Broselow tape. A blinded 10mL syringe containing study drug was prepared and delivered to the bedside by a pharmacist. After administration of study drug all future analgesic doses were restricted to morphine and were given at the discretion of the treatment team. | 32 |
| Total | 63 |
Baseline characteristics
| Characteristic | Morphine | Ketamine | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 32 Participants | 31 Participants | 63 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 12.7 years STANDARD_DEVIATION 3.7 | 13.3 years STANDARD_DEVIATION 3.6 | 13.0 years STANDARD_DEVIATION 3.7 |
| Region of Enrollment United States | 32 participants | 31 participants | 63 participants |
| Sex: Female, Male Female | 9 Participants | 12 Participants | 21 Participants |
| Sex: Female, Male Male | 23 Participants | 19 Participants | 42 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 31 | 2 / 32 |
| serious Total, serious adverse events | 0 / 31 | 0 / 32 |
Outcome results
Primary
Adverse Drug Reaction
Rate of pain medication related adverse events during their ED stay and at 24 hours post discharge from the ED. the research team will complete the Adverse Event case report form to determine any adverse events occurring during the study period. Family members will be contacted via telephone 24 hours (±8 hours) following their visit in the Emergency Department to complete the Discharge Adverse Event case report form.
Time frame: 3 hours post study drug administration
Population: Rate of pain medication related adverse events during their ED stay and at 24 hours post discharge from the ED will be compared using unadjusted Fisher's exact of a composite measure (≤ 1 events vs. \> 1).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ketamine | Adverse Drug Reaction | 2 Participants |
| Morphine | Adverse Drug Reaction | 3 Participants |
Primary
Cumulative Narcotic Consumption
All opioids administered were converted to morphine equivalents in milligrams (eq. mg) via standard equianalgesic calculations. Pre-study drug opioids information was also collected.The number of subjects who received a morphine dose after administration of the study drug, both within one hour or at all was included in the outcome measure results.
Time frame: 3 hours post study drug administration
Population: The number of subjects in each group who received at least one dose of opioids post study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ketamine | Cumulative Narcotic Consumption | 19 Participants |
| Morphine | Cumulative Narcotic Consumption | 14 Participants |
Other Pre-specified
Pain Scale Rating Agreement Among Patient, Parent, and Research Staff
FLACC scores were assessed on the patient using the FLACC scale (0-10) by the parent, treating RN/trained research assistant. * FLACC - Parents 30 Minutes Post dose * FLACC - Staff 30 Minutes Post dose Wong-Baker Faces scale is a self-assessment of pain Scale of 1-10 pain.
Time frame: Up to 3 hours post pain medication administration
Population: Wong-Baker Faces scale is a self-assessment of pain Scale. FLACC Score (FLACC = Face, Legs, Activity, Crying and Consolability) is a behavioral observational pain rating scale that looks for specific behaviors and scores them. Both scales are scored 0-10 with 0 representing no pain. Lower scores are better outcomes.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ketamine | Pain Scale Rating Agreement Among Patient, Parent, and Research Staff | FLACC - Staff 30 Minutes Post dose | 1.1 Scores on a scale | Standard Deviation 1.7 |
| Ketamine | Pain Scale Rating Agreement Among Patient, Parent, and Research Staff | FLACC - Parents 30 Minutes Post dose | 2.0 Scores on a scale | Standard Deviation 2.1 |
| Ketamine | Pain Scale Rating Agreement Among Patient, Parent, and Research Staff | Wong-Baker Faces pain scale changes | -3.5 Scores on a scale | Standard Deviation 2.4 |
| Morphine | Pain Scale Rating Agreement Among Patient, Parent, and Research Staff | Wong-Baker Faces pain scale changes | -3.7 Scores on a scale | Standard Deviation 2.4 |
| Morphine | Pain Scale Rating Agreement Among Patient, Parent, and Research Staff | FLACC - Staff 30 Minutes Post dose | 1.1 Scores on a scale | Standard Deviation 1.6 |
| Morphine | Pain Scale Rating Agreement Among Patient, Parent, and Research Staff | FLACC - Parents 30 Minutes Post dose | 1.9 Scores on a scale | Standard Deviation 1.9 |