Study to Find the Dose of Rapidly Administered Ketamine for Brief Painful Procedures in Children

NCT01669642 | Completed Results DMC

• 1 other identifier: 201112017
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to find the dose of rapidly administered ketamine in 3 different pediatric age groups (2-5, 6-11 and 12-17) for abscess drainage and fracture reduction. Ketamine is the most common drug administered to children to facilitate painful procedures in the emergency setting because it achieves potent sedation, pain relief and amnesia with minimal adverse cardiopulmonary effects.(1-5) However, the 1-2 hour recovery period (1,6) associated with standard ketamine administration guidelines(7) strains work flow because it requires bedside one-on-one nurse monitoring in a treatment room, tying up these limited and valuable resources. Consequently, a combination of two other drugs, propofol + fentanyl (P/F), with recovery of 20-30 minutes, is rapidly gaining popularity for procedural sedation despite more frequent respiratory depression, apnea and hypotension caused by this technique.(2,4,8,9) The investigators believe recovery associated with our novel method for administering ketamine is significantly shorter than with the standard larger dose more slowly administered ketamine technique(7). Through the investigators clinical experience, the investigators have found rapid infusion of smaller than standard doses of ketamine safely achieves the drug's sedative effect, with the benefit of more rapid recovery due to the use of a smaller dose. However, this novel technique challenges published beliefs that time of recovery from ketamine sedation does not differ significantly with the dose administered, within the usual dose ranges, and that rapid infusion may cause respiratory depression, similar to that seen with other classes of sedative-analgesic drugs.(7,10) the investigators believe the slow infusion recommended by standard guidelines(7) requires a larger ketamine dose necessary to achieve effective sedation, and, consequently, prolongs recovery. It is the prolonged recovery that has prompted increased use of other less safe but briefer sedatives, such as propofol/fentanyl. By demonstrating patients recover rapidly with new ketamine technique, without increased adverse cardiopulmonary effects, the investigators will provide clinicians with an important new method for ketamine procedural sedation. The investigators believe clinicians will prefer more rapid recovery ketamine technique because it is safer and reduces pain and distress better than the propofol/fentanyl combination for sedation. The investigators complete proposal requires two steps. In Step One, this proposal, the investigators will determine the minimum effective dose of rapidly infused ketamine that achieves deep sedation for at least 5 minutes in 95% of children (ED95). Two groups of patients will be studied: one group is patients undergoing abscess incision and drainage and the other group is patients undergoing fracture reduction in our Emergency Department. The investigators believe that the ED95 is different for both the groups as the severity of pain is different. The investigators will compare the safety and recovery times to published standard ketamine techniques. In the following study, Step Two, the investigators will compare this novel technique, in a blinded randomized trial using the ED95 ketamine dose determined in Step One to the standard ketamine technique to determine if the novel technique results in significantly shorter recovery without an increase in the frequency of adverse effects. The study the investigators are proposing in this submission is Step One only.

Conditions

Abscess; Fracture

Keywords

ketamine sedation; pediatric; abscess drainage; fracture reduction

Outcome Measures

Primary Outcomes (2)

• Median Effective Dose (ED50) and ED95 of Rapidly Administered Ketamine

  ED50 is the dose of rapidly administered ketamine that achieves effective sedation in 50% of patients. ED95 is the dose of ketamine that can provide effective sedation in 95% of children undergoing abscess drainage or fracture reduction. ED95 will be calculated for the 3 age groups (2-5, 6-11 and 12-17) independently for both the procedures: abscess drainage and fracture reduction.

  Dose administration through 5 minutes

• ED95

  ED95 is the dose of ketamine effective for 95% of children. this outcome is estimated from ED50.

  Dose administration through 5 minutes

Secondary Outcomes (2)

• Vomiting

  Administration of ketamine through 2 week follow up call

• Number of Participants With Wisconsin Sedation Scale Score of 2 or Less at 1 Minute After First Dose of Ketamine

  Dose administration through 1 minute

Other Outcomes (1)

• Total Sedation Time

  Time of administration of ketamine through sedation recovery

Study Arms (1)

Ketamine

EXPERIMENTAL

participants who get the ketamine sedation will be enrolled. there is no control or comparison group.

Drug: Ketamine

Interventions

Ketamine DRUG

participants who need ketamine sedation for abscess drainage or fracture reduction will be approached for enrollment. there is no comparison group. A predetermined dose of Ketamine will be administered over 5 seconds or less intravenously. Sedation provider will assess for effectiveness of sedation at one minute.

Also known as: Ketalar

Ketamine

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Healthy children (ASA Physical Status I and II) 2-17 yrs old who require deep sedation for abscess incision and drainage in the St. Louis Children's Hospital Emergency Unit

You may not qualify if:

• Fever (temperature ≥ 38 0Celcius) due to upper respiratory infection.
• Obesity (BMI \> 2SD for age and sex) or undernourishment (BMI \< 2SD for age and sex)
• Previous adverse reactions with ketamine sedation
• Receipt of opioid analgesic in the ED (oxycodone/morphine etc) prior to sedation
• Multiple abscesses (2 or more) requiring I \& D
• Non -English speaking families
• Children under foster care.
• Previous participation in current research study

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

St Louis Children's hospital, Washington university

St Louis, Missouri, 63123, United States

Location

MeSH Terms

Conditions

Abscess; Fractures, Bone

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Suppuration; Infections; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: SRI SANKAR CHINTA PI
• Organization: washington university in st louis

schinta@wustl.edu

3144544661

Study Officials

• sri s chinta, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2012
• First Posted: August 21, 2012
• Study Start: April 1, 2012
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: April 25, 2019
• Results First Posted: March 12, 2018

Record last verified: 2019-04

Locations

US (1)