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Optimal Dosing of Ketamine for Procedural Sedation and Analgesia in Children

Optimal Dosing of Ketamine for Procedural Sedation and Analgesia in Children

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02519595
Enrollment
182
Registered
2015-08-11
Start date
2010-08-31
Completion date
2012-08-31
Last updated
2016-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Moderate, Deep Sedation

Keywords

Procedural sedation, ketamine, children

Brief summary

There is a wide variation of published IV ketamine dosing regimens used for procedural sedation in children in the Emergency Department (ED). The purpose of the study was to compare the efficacy, duration of sedation and adverse events between the three commonly administered doses of IV ketamine (1 mg/kg, 1.5 mg/kg and 2 mg/kg) using the traditional administration method of 30-60 second infusion for ED sedation in children.

Detailed description

This was a prospective, double-blind, randomized controlled trial of children aged 3 to 18 years who received IV ketamine for procedural sedation and analgesia (PSA) for orthopedic procedures, incision and drainage (I & D) of skin abscess and laceration repair in an inner city, tertiary care pediatric ED. Random sequence allocation was performed using a computer-generated, random number table by the study research pharmacist. The study participants were grouped according to their age as follows (1) 3-6 years (2) 7-12 years (3) 13-18 years. Children from each age group were assigned in equal numbers to all three ketamine dosing (1 mg/kg, 1.5 mg/kg and 2 mg/kg) groups using random permuted blocks stratified by the pharmacist. All ED staff including the physician and the nurse in charge of sedation, the study research assistant, the parents/guardians and the study subjects were blinded to the randomization and the group assignments. The dosage and administration of additional doses of ketamine were left to the discretion of the ED physician in charge of the sedation. The research team did not participate in the clinical care including sedation of the patient. Children were monitored per ED policy for the entire duration of sedation. Three 1 ml blood samples for the ketamine assay was collected from the existing intravenous access at three time intervals: 3-5 minutes after ketamine administration, at midpoint during the procedure and prior to discharge of the patient from the ED. In the event a second dose of ketamine was administered, a 4th 1 ml sample was collected 3-5 minutes after the 2nd dose in children weighing \>20 kilograms. Patient demographics, procedure type, NPO status , ASA classification, pain medication administered prior to sedation (timing, dosage and type), number and total doses of ketamine administered after the initial study dose, sedation efficacy and duration, length of procedure, adverse events related to sedation, interventions performed to address the adverse events and patient disposition were collected. The study research assistant also performed a follow up phone call to the parents/caregivers of the children 48 hours after ED discharge to collect information on adverse events that happened at home . A total of 3 attempts were made to contact the parent/caregiver after which the participant was considered as lost to followup.

Interventions

DRUGKetamine IV 1mg/kg

Intervention: Ketamine IV 1mg/kg

DRUGKetamine IV 1.5mg/kg

Intervention: Ketamine IV 1.5 mg/kg

DRUGKetamine IV 2mg/kg

Intervention: Ketamine IV 2 mg/kg

Sponsors

Children's Hospital of Michigan
Lead SponsorOTHER

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 18 Years
Healthy volunteers
No

Inclusion criteria

* Children 3 -18 years of age * Belonging to American Society of Anesthesiologists (ASA) classification 1 or 2 * Receiving IV ketamine for procedural sedation for orthopedic procedures, * Incision and Drainage of skin abscess and laceration repair

Exclusion criteria

* Contraindications to use of Ketamine * Parents or legal guardian not available or declined to provide informed consent * Child declined to provide assent, * Patients that received intramuscular ketamine, * Patient that received benzodiazepines in addition to ketamine * Children weighing \>100 kilogram * Children with developmental disabilities.

Design outcomes

Primary

MeasureTime frameDescription
Sedation EfficacyParticipants will be assessed after study drug adminsitration and the maximum depth of sedation achieved recorded. Approximately 2 hoursMeasure sedation depth using Ramsay Sedation Scale. Varies from 1-6 with 1: anxious, agitated, restless 2: Cooperative, oriented, tranquil 3: responsive to commands 4: Brisk response to light glabellar tap or auditory stimulus 5: Sluggish response to light glabellar tap or loud auditory stimulus 6 being no response to light glabellar tap or loud auditory stimulus. Higher the score, greater is the depth of sedation. Use of ketamine usually provides a depth of sedation of 5 or 6.
PainPatients will be assessed during the procedure after administration of sedation medicaiton. Approximately 30 minutesMeasure pain using self reported Wong Baker faces pain rating scale prior to sedation, during sedation and prior to discharge.The scale shows a series of faces ranging from a happy face at 0, No hurt to a crying face at 10 Hurts worst. The patient must choose the face that best describes how they are feeling. The score has values of 0(no hurt), 2(hurts little bit), 4(hurts little more), 6(hurts even more), 8(hurts whole lot),10 (hurts worst). The patient chooses one number that describes the pain best (eg. Either a 2 or 4).

Secondary

MeasureTime frameDescription
Sedation DurationPatients will be assessed during the length of time from administration of sedation medication until ready for discharge, Approximately 3 hoursLength of sedation was defined as the time duration from the administration of study medication until ready for discharge using standardized discharge criteria (Aldrete scoring \>9) followed at our institution.
Additional DosePatients will be assessed during procedure . Approximately 1 hoursNumber of participants to whom additional doses of ketamine administered apart from the study dose
Adverse EventsPatients will be assessed after administration of medication until discharge and will have a follow up phone call 48 hours after discharge for 3 attempts. 5 days.,Adverse events secondary to sedation experienced by the patient and interventions performed to overcome them
Sedation SatisfactionAt the end of the procedure. Approximately 1 hourConsultants will be asked to rate their level of satisfaction with sedation on a Likert Scale of 1-3

Participant flow

Recruitment details

Conducted at a level 1 trauma Pediatric Emergency Department from July 1st 2010 to August 31st 2012. We enrolled a convenience sample of eligible patients. Study participants were identified using the electronic medical tracking board which lists the presenting complaint and after need for IV ketamine sedation was established with physician.

Pre-assignment details

11 consented patients were excluded as sedation and procedure was performed in the operating room rather than in the Emergency Department

Participants by arm

ArmCount
Ketamine IV 1 mg/kg
Intervention: A blinded dose of 1mg/kg IV ketamine is administered to patients Ketamine IV 1mg/kg: Intervention: Ketamine IV 1mg/kg
50
Ketamine IV 1.5 mg/kg
Intervention: A blinded dose of 1.5mg/kg IV ketamine is administered to patients Ketamine IV 1.5mg/kg: Intervention: Ketamine IV 1.5 mg/kg
35
Ketamine IV 2 mg/kg
Intervention: A blinded dose of 2 mg/kg IV ketamine is administered to patients Ketamine IV 2mg/kg: Intervention: Ketamine IV 2 mg/kg
40
Total125

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Overall StudyProtocol Violation82216

Baseline characteristics

CharacteristicTotalKetamine IV 2 mg/kgKetamine IV 1.5 mg/kgKetamine IV 1 mg/kg
Age, Customized
13-18 years
16 participants6 participants4 participants6 participants
Age, Customized
3-6 years
56 participants16 participants18 participants22 participants
Age, Customized
7-12 years
53 participants18 participants13 participants22 participants
AMerican Society of Anesthesiologists (ASA) Category
ASA Class 1, A normal healthy patient
119 participants37 participants32 participants50 participants
AMerican Society of Anesthesiologists (ASA) Category
ASA class 2, Mild systemic disease
5 participants3 participants2 participants0 participants
AMerican Society of Anesthesiologists (ASA) Category
ASA class 3, Severe systemic disease
1 participants0 participants1 participants0 participants
Ethnicity (NIH/OMB)
Hispanic or Latino
14 Participants6 Participants1 Participants7 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
102 Participants32 Participants31 Participants39 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
9 Participants2 Participants3 Participants4 Participants
Procedure Type
Fracture/Dislocation Reduction
89 participants35 participants21 participants33 participants
Procedure Type
Incision and Drainage
25 participants2 participants11 participants12 participants
Procedure Type
Laceration Repair
11 participants3 participants3 participants5 participants
Race (NIH/OMB)
American Indian or Alaska Native
2 Participants0 Participants0 Participants2 Participants
Race (NIH/OMB)
Asian
2 Participants1 Participants0 Participants1 Participants
Race (NIH/OMB)
Black or African American
66 Participants18 Participants27 Participants21 Participants
Race (NIH/OMB)
More than one race
5 Participants1 Participants0 Participants4 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
18 Participants9 Participants3 Participants6 Participants
Race (NIH/OMB)
White
32 Participants11 Participants5 Participants16 Participants
Sex: Female, Male
Female
54 Participants13 Participants18 Participants23 Participants
Sex: Female, Male
Male
71 Participants27 Participants17 Participants27 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —
other
Total, other adverse events
5 / 505 / 354 / 40
serious
Total, serious adverse events
0 / 500 / 350 / 40

Outcome results

Primary

Pain

Measure pain using self reported Wong Baker faces pain rating scale prior to sedation, during sedation and prior to discharge.The scale shows a series of faces ranging from a happy face at 0, No hurt to a crying face at 10 Hurts worst. The patient must choose the face that best describes how they are feeling. The score has values of 0(no hurt), 2(hurts little bit), 4(hurts little more), 6(hurts even more), 8(hurts whole lot),10 (hurts worst). The patient chooses one number that describes the pain best (eg. Either a 2 or 4).

Time frame: Patients will be assessed during the procedure after administration of sedation medicaiton. Approximately 30 minutes

ArmMeasureValue (MEDIAN)
Ketamine IV 1 mg/kgPain0 units on a scale
Ketamine IV 1.5 mg/kgPain0 units on a scale
Ketamine IV 2 mg/kgPain0 units on a scale
p-value: 0.09Kruskal-Wallis
Primary

Sedation Efficacy

Measure sedation depth using Ramsay Sedation Scale. Varies from 1-6 with 1: anxious, agitated, restless 2: Cooperative, oriented, tranquil 3: responsive to commands 4: Brisk response to light glabellar tap or auditory stimulus 5: Sluggish response to light glabellar tap or loud auditory stimulus 6 being no response to light glabellar tap or loud auditory stimulus. Higher the score, greater is the depth of sedation. Use of ketamine usually provides a depth of sedation of 5 or 6.

Time frame: Participants will be assessed after study drug adminsitration and the maximum depth of sedation achieved recorded. Approximately 2 hours

ArmMeasureValue (MEDIAN)
Ketamine IV 1 mg/kgSedation Efficacy5.5 units on a scale
Ketamine IV 1.5 mg/kgSedation Efficacy6 units on a scale
Ketamine IV 2 mg/kgSedation Efficacy6 units on a scale
p-value: 0.2Kruskal-Wallis
Secondary

Additional Dose

Number of participants to whom additional doses of ketamine administered apart from the study dose

Time frame: Patients will be assessed during procedure . Approximately 1 hours

ArmMeasureValue (NUMBER)
Ketamine IV 1 mg/kgAdditional Dose8 participants
Ketamine IV 1.5 mg/kgAdditional Dose1 participants
Ketamine IV 2 mg/kgAdditional Dose2 participants
Secondary

Adverse Events

Adverse events secondary to sedation experienced by the patient and interventions performed to overcome them

Time frame: Patients will be assessed after administration of medication until discharge and will have a follow up phone call 48 hours after discharge for 3 attempts. 5 days.,

ArmMeasureGroupValue (NUMBER)
Ketamine IV 1 mg/kgAdverse EventsAdverse events in ED5 participants
Ketamine IV 1 mg/kgAdverse EventsPost discharge Emesis4 participants
Ketamine IV 1.5 mg/kgAdverse EventsAdverse events in ED5 participants
Ketamine IV 1.5 mg/kgAdverse EventsPost discharge Emesis4 participants
Ketamine IV 2 mg/kgAdverse EventsAdverse events in ED4 participants
Ketamine IV 2 mg/kgAdverse EventsPost discharge Emesis6 participants
Comparison: Adverse events in EDp-value: 0.8Chi-squared
Comparison: Post discharge Emesisp-value: 0.5Chi-squared
Secondary

Sedation Duration

Length of sedation was defined as the time duration from the administration of study medication until ready for discharge using standardized discharge criteria (Aldrete scoring \>9) followed at our institution.

Time frame: Patients will be assessed during the length of time from administration of sedation medication until ready for discharge, Approximately 3 hours

ArmMeasureValue (MEDIAN)
Ketamine IV 1 mg/kgSedation Duration23 Minutes
Ketamine IV 1.5 mg/kgSedation Duration24.5 Minutes
Ketamine IV 2 mg/kgSedation Duration23 Minutes
p-value: 0.2Kruskal-Wallis
Secondary

Sedation Satisfaction

Consultants will be asked to rate their level of satisfaction with sedation on a Likert Scale of 1-3

Time frame: At the end of the procedure. Approximately 1 hour

Population: consultant satisfaction missing in 6 participants

ArmMeasureGroupValue (NUMBER)
Ketamine IV 1 mg/kgSedation SatisfactionVery Satisfied27 participants
Ketamine IV 1 mg/kgSedation SatisfactionNot satisfied10 participants
Ketamine IV 1 mg/kgSedation SatisfactionSatisfied12 participants
Ketamine IV 1.5 mg/kgSedation SatisfactionVery Satisfied29 participants
Ketamine IV 1.5 mg/kgSedation SatisfactionSatisfied3 participants
Ketamine IV 1.5 mg/kgSedation SatisfactionNot satisfied2 participants
Ketamine IV 2 mg/kgSedation SatisfactionVery Satisfied29 participants
Ketamine IV 2 mg/kgSedation SatisfactionSatisfied6 participants
Ketamine IV 2 mg/kgSedation SatisfactionNot satisfied1 participants
p-value: 0.011Chi-squared

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026