Optimal Dosing of Ketamine for Procedural Sedation and Analgesia in Children

NCT02519595 | Completed Phase 4 Results

• 1 other identifier: R1-2013-88
• Study Type: interventional
• Target: 182
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Moderate, Deep Sedation

Keywords

Procedural sedation; ketamine; children

Outcome Measures

Primary Outcomes (2)

• 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.

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

• 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).

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

Secondary Outcomes (4)

• Sedation Duration

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

• Additional Dose

  Patients will be assessed during procedure . Approximately 1 hours

• Adverse Events

  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.,

• Sedation Satisfaction

  At the end of the procedure. Approximately 1 hour

Study Arms (3)

ketamine IV 1 mg/kg

EXPERIMENTAL

Intervention: A blinded dose of 1mg/kg IV ketamine is administered to patients

Drug: Ketamine IV 1mg/kg

Ketamine IV 1.5 mg/kg

EXPERIMENTAL

Intervention: A blinded dose of 1.5mg/kg IV ketamine is administered to patients

Drug: Ketamine IV 1.5mg/kg

Ketamine IV 2 mg/kg

EXPERIMENTAL

Intervention: A blinded dose of 2 mg/kg IV ketamine is administered to patients

Drug: Ketamine IV 2mg/kg

Interventions

Ketamine IV 1mg/kg DRUG

Intervention: Ketamine IV 1mg/kg

ketamine IV 1 mg/kg

Ketamine IV 1.5mg/kg DRUG

Intervention: Ketamine IV 1.5 mg/kg

Ketamine IV 1.5 mg/kg

Ketamine IV 2mg/kg DRUG

Intervention: Ketamine IV 2 mg/kg

Ketamine IV 2 mg/kg

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Hospital of Michigan: lead

MeSH Terms

Conditions

Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Limitations and Caveats

Convenience sample of patients enrolled. One fourth of patients did not receive the dose that they were randomized to. We did not enroll children \<3 years. We did not randomize by procedure type which could have confounded length of sedation.

Results Point of Contact

• Title: Nirupama Kannikeswaran
• Organization: Children's Hospital of Michigan

nkannike@dmc.org

313-745-5260

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: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics and Emergency Medicine

Study Record Dates

• First Submitted: August 5, 2015
• First Posted: August 11, 2015
• Study Start: August 1, 2010
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: October 12, 2016
• Results First Posted: October 12, 2016

Record last verified: 2016-08