IN Ketamine vs IN Midazolam and Fentanyl for Laceration Repair

NCT03528512 | Terminated Phase 4 Results DMC FDA Drug

• 1 other identifier: 2017-363
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

Often, repair of the cuts (laceration repair) proves to be traumatic for the children and the parents. Nasal spray (Intranasal/IN) approaches for procedural pain reduction, such as during dental work, have been demonstrated to make drug administration painless and well tolerated. We are comparing IN ketamine to IN midazolam and fentanyl for pain and reducing anxiety during repair of cuts in children.

Conditions

Laceration of Skin

Keywords

Pediatric; analgesia; pain control; sedation; intranasal ketamine; intranasal midazolam; intranasal fentanyl

Outcome Measures

Primary Outcomes (2)

• Sedation Score

  The primary outcome variable is the maximum sedation score as measured by the University of Michigan Sedation Scale. This scale consists of an ordinal scale from 0 being awake and alert and 4 being unarousable. Medians will be calculated for each group.

  up to 30 minutes

• Proportion of Children With Maximum Sedation Score

  The proportion of children who receive a maximum sedation score of either 1 or 2 (without distinguishing between those values)

  Up to 30 minutes

Secondary Outcomes (4)

• Pain Scores During Laceration Repair

  Up to 30 minutes

• Nurse and Physician Satisfaction

  Up to 30 minutes

• Rates of Failure

  Up to 30 minutes

• Change in Vitals

  up to 30 minutes

Study Arms (2)

IN ketamine

EXPERIMENTAL

Intranasal ketamine 3mg/kg (max 100 mg) + saline 0.03 ml/kg (max 2ml)

Drug: Ketamine

IN midazolam and fentanyl

ACTIVE COMPARATOR

Intranasal midazolam 0.3 mg/kg (max 10 mg) + fentanyl 1.5mcg/kg (max 100 mcg)

Drug: Midazolam and fentanyl

Interventions

Ketamine DRUG

Intranasal ketamine 3mg/kg (max 100 mg) + saline 0.03 ml/kg (max 2ml)

IN ketamine

Midazolam and fentanyl DRUG

Intranasal midazolam 0.3 mg/kg (max 10 mg) + fentanyl 1.5mcg/kg (max 100 mcg)

IN midazolam and fentanyl

Eligibility Criteria

• Age: 6 Months - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Pediatric patients 6 months to 10 years who required laceration repair in the pediatric emergency center.
• Laceration should be less than 5 cm long, require 2 or more sutures and no consult subspeciality consult for repair.
• Topical anesthetic (lidocaine-epinephrine-tetracaine topical solution/XAP) will be applied to all lacerations for 20 minutes duration before giving the intranasal medications.

You may not qualify if:

• Age \< 6 months
• Documented allergy or adverse effect to ketamine, midazolam or fentanyl
• Epistaxis
• Partial upper airway obstruction
• Oxygen requirement via nasal cannula
• Acute mental status changes (e.g. obtunded or somnolent)
• Documented increased intracranial pressure or increased ocular pressure
• Documented porphyria
• Previously involved in the study
• Parent or patient refusal
• Acutely compromised vitals (hypotension, desaturations, respiratory distress)
• Any known heart disease
• If any previous opioid use for analgesia during the visit
• Need for staples
• Scalp wounds

Sponsors & Collaborators

• Corewell Health East: lead

Study Sites (1)

Beaumont Hospital - Royal Oak

Royal Oak, Michigan, 48073, United States

Location

MeSH Terms

Conditions

Agnosia

Interventions

Ketamine; Midazolam; Fentanyl

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Piperidines; Heterocyclic Compounds, 1-Ring

Limitations and Caveats

Study terminated early because staffing was eliminated. No results analyzed due to population size.

Results Point of Contact

• Title: Dr. Margaret Menoch
• Organization: William Beaumont Hospitals

margaret.menoch@beaumont.edu

2489897289

Study Officials

• Kelly Levasseur, DO

  Corewell Health East

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: A randomization list created by an online randomization tool will be used to assign participants to a treatment arm (in random blocks of 4, 6, and 8). As participants are enrolled in the study, they will be assigned to the next available sequential treatment arm.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric ER Medical Clinical Faculty

Model Details: Randomized double blinded control trial

Study Record Dates

• First Submitted: May 5, 2018
• First Posted: May 18, 2018
• Study Start: September 4, 2018
• Primary Completion: February 6, 2019
• Study Completion: February 6, 2019
• Last Updated: August 24, 2021
• Results First Posted: August 24, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)