Intranasal Versus Intravenous Ketamine for Procedural Sedation in Children With Non-operative Fractures
Status: | Not yet recruiting |
---|---|
Conditions: | Hospital, Orthopedic |
Therapuetic Areas: | Orthopedics / Podiatry, Other |
Healthy: | No |
Age Range: | 1 - 18 |
Updated: | 12/23/2018 |
Start Date: | June 1, 2019 |
End Date: | January 1, 2021 |
Contact: | James Statler, MD |
Email: | jstatler@uabmc.edu |
Phone: | 205-638-6098 |
This a randomized clinical trial involving children with non-operative fractures presenting
the emergency department randomized either to intranasal or intravenous ketamine.
the emergency department randomized either to intranasal or intravenous ketamine.
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.
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.
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
We found this trial at
1
site
1720 2nd Ave S
Birmingham, Alabama 35233
Birmingham, Alabama 35233
(205) 934-4011
Phone: 205-638-6098
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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