Intranasal Versus Intravenous Ketamine for Procedural Sedation in Children With Non-operative Fractures

Sponsor

University of Alabama at Birmingham (Other)

Overall Status

Terminated

CT.gov ID

NCT03781817

Collaborator

(none)

Enrollment

Location

Arms

31.7

Actual Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This a randomized clinical trial involving children with non-operative fractures presenting the emergency department randomized either to intranasal or intravenous ketamine.

Condition or Disease	Intervention/Treatment	Phase
Trauma Fractures, Closed Children, Only Deep Sedation Ketamine	Drug: Intravenous Ketamine Drug: Intranasal Ketamine	Phase 4

Detailed Description

The purpose of this study is to determine if Intranasal Ketamine (INK) is efficacious for Procedural Sedation and Analgesia (PSA) when compared to Intravenous Ketamine (IVK) in children with non-operative fractures. The primary aim is to determine if INK provides non-inferior sedation to IVK as defined by a Modified Ramsay Sedation score of ≥ 4 and also to compare the proportion of successful procedure between two treatment groups. The secondary aim is to compare proportion of adverse events and compare duration of sedation and length of emergency department (ED) stay between treatment groups.

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Intranasal Versus Intravenous Ketamine for Procedural Sedation in Children With Non-operative Fractures

Actual Study Start Date :

Sep 9, 2019

Actual Primary Completion Date :

Jan 21, 2022

Actual Study Completion Date :

Apr 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Intravenous ketamine Participants randomized to IV ketamine will be receive IV ketamine and Intranasal normal saline.	Drug: Intravenous Ketamine Subject randomized to IV Ketamine arm will receive IN Normal Saline at induction. After 8 minutes subjects will receive IV Ketamine (10 mg/mL) at a dose of 1.5 mg/kg. Level of sedation will be scored at the 15 minutes from induction to determine if adequate sedation has been achieved.
Experimental: Intranasal ketamine Participants randomized to Intranasal Ketamine group will receive Intranasal ketamine and IV normal saline.	Drug: Intranasal Ketamine Subject randomized to IN Ketamine arm will receive IN Ketamine (100 mg/mL) at a dose of 9 mg/kg at induction. After 8 minutes subjects will receive IV Normal Saline. Level of sedation will be scored at the 15 minutes from induction to determine if adequate sedation has been achieved.

Arm

Intervention/Treatment

Active Comparator: Intravenous ketamine

Participants randomized to IV ketamine will be receive IV ketamine and Intranasal normal saline.

Drug: Intravenous Ketamine

Subject randomized to IV Ketamine arm will receive IN Normal Saline at induction. After 8 minutes subjects will receive IV Ketamine (10 mg/mL) at a dose of 1.5 mg/kg. Level of sedation will be scored at the 15 minutes from induction to determine if adequate sedation has been achieved.

Experimental: Intranasal ketamine

Participants randomized to Intranasal Ketamine group will receive Intranasal ketamine and IV normal saline.

Drug: Intranasal Ketamine

Subject randomized to IN Ketamine arm will receive IN Ketamine (100 mg/mL) at a dose of 9 mg/kg at induction. After 8 minutes subjects will receive IV Normal Saline. Level of sedation will be scored at the 15 minutes from induction to determine if adequate sedation has been achieved.

Outcome Measures

Primary Outcome Measures

Achieved adequate sedation as evidenced by Modified Ramsay Sedation score. [Induction up to 5 minutes]
Determine if IN ketamine provides non-inferior sedation to IV ketamine as defined by a Modified Ramsay Sedation score of ≥ 4. Modified Ramsay Sedation scale is used to evaluate levels of sedation. The scale range is from 0 to 6 with a higher score indicated deeper levels of sedation. At levels of 4 or greater is set to be satisfactory for deep sedation.
Achieved adequate sedation as evidenced by Modified Ramsay Sedation score. [From 5 minutes to 10 minutes]
Determine if IN ketamine provides non-inferior sedation to IV ketamine as defined by a Modified Ramsay Sedation score of ≥ 4. Modified Ramsay Sedation scale is used to evaluate levels of sedation. The scale range is from 0 to 6 with a higher score indicated deeper levels of sedation. At levels of 4 or greater is set to be satisfactory for deep sedation.
Achieved adequate sedation as evidenced by Modified Ramsay Sedation score. [From 10 minutes to 15 minutes]
Determine if IN ketamine provides non-inferior sedation to IV ketamine as defined by a Modified Ramsay Sedation score of ≥ 4. Modified Ramsay Sedation scale is used to evaluate levels of sedation. The scale range is from 0 to 6 with a higher score indicated deeper levels of sedation. At levels of 4 or greater is set to be satisfactory for deep sedation.
Percentage of adequately sedated participants successfully completing the procedure without requiring rescue medications. [From induction to 60 minutes.]
Rescue medication is defined as requiring additional doses of Ketamine to maintain adequate sedation. Successful procedure completion will be define as completing the procedure with only the induction dose and without requiring rescue medications.

Secondary Outcome Measures

Proportions of patients with non-serious adverse events. [From induction to 6 hours.]
Non-serious adverse events include allergic reaction, vomiting, emergence agitation, and oxygen desaturations.
Duration of sedation using Modified Ramsay Sedation scale. [From induction to 6 hours.]
Modified Ramsay Sedation scale is used to evaluate levels of sedation. The scale range is from 0 to 6 with a higher score indicated deeper levels of sedation. At levels of 2 or less is set to be satisfactory for discharge from sedation.
Duration of emergency department stay. [From arrival to emergency department to 6 hours.]
Measured from time of arrival to emergency department to discharge order.

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Children 1-18 years of age.
American Society of Anesthesiologists (ASA) I or II
Non-operative fracture requiring reduction
Body weight less than or equal to 25 kg as measured by standard weighing scale

Exclusion Criteria:

ASA classification III or above
Age less than 1 year
History of hypertension, known coronary artery disease or Kawasaki disease, congestive heart failure, acute glaucoma or globe injury, increased intracranial pressure or intracranial mass lesion, acute porphyria, developmental delays, or major psychiatric disorder
Prior allergy to ketamine
Unavailable parent or guardian to provide consent
Non-English speaking