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IN Ketamine vs IN Midazolam and Fentanyl for Laceration Repair

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ClinicalTrials.gov Identifier: NCT03528512
Recruitment Status : Recruiting
First Posted : May 18, 2018
Last Update Posted : July 31, 2020
Sponsor:
Information provided by (Responsible Party):
Kelly Levasseur, DO, William Beaumont Hospitals

Tracking Information
First Submitted Date  ICMJE May 5, 2018
First Posted Date  ICMJE May 18, 2018
Last Update Posted Date July 31, 2020
Actual Study Start Date  ICMJE September 4, 2018
Estimated Primary Completion Date February 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 5, 2018)
  • Sedation Score [ Time Frame: up to 30 minutes ]
    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.
  • Proportion of children with maximum sedation score [ Time Frame: Up to 30 minutes ]
    The proportion of children who receive a maximum sedation score of either 1 or 2 (without distinguishing between those values)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 5, 2018)
  • Pain scores during laceration repair [ Time Frame: Up to 30 minutes ]
    The effect of IN ketamine vs IN midazolam + IN fentanyl on pain scores during laceration repair using either Face, Legs, Activity, Cry, Consolability (FLACC) Scale or Faces Scale pain scale depending for patient age, each a Likert scale from 0 being no pain to 10 being worst pain, median scores for each group
  • Nurse and physician satisfaction [ Time Frame: Up to 30 minutes ]
    Nurse and physician satisfaction will be assessed by a survey which will be filled in the end of the sedation. Response to overall experience question score on Likert scale where 1 is poor and 5 is Excellent. Proportion of responders giving answers of 4 or 5 will be calculated.
  • Rates of failure [ Time Frame: Up to 30 minutes ]
    Rates of failure to repair laceration due to agitation or intolerable pain with the switch to intravenous medications will be compared between two groups. Percentage failure will be reported.
  • Change in vitals [ Time Frame: up to 30 minutes ]
    Proportion of children who have any significant change in vitals during analgosedation (any desaturation - Oxygen saturation < 90, and hypotension per age-related norms) will be compared between the two groups.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE IN Ketamine vs IN Midazolam and Fentanyl for Laceration Repair
Official Title  ICMJE Comparison of Sedation, Pain, and Care Provider Satisfaction Between the Use of Intranasal Ketamine Versus Intranasal Midazolam and Fentanyl During Laceration Repair
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.
Detailed Description

Children frequently present to pediatric emergency center (PEC) with cuts of different body parts. Often, repair of the cuts (laceration repair) proves to be traumatic for the children and the parents alike. Ideally, repair of the cuts should be as painless and free from anxiety as possible. To work towards this goal, different analgesic (pain drugs) and sedative ( to calm patients down) management strategies use intravenous (into the vein), intramuscular ( into the muscle) and, more recently, intranasal (into the nostrils) routes. Unfortunately, intravenous access is hard to establish and may be painful for the child. The intramuscular route is often similarly painful. Due to the rich blood supply and large surface area of the nasal vestibule, intranasally (IN) administered medications are highly absorbed. IN approaches for procedural pain reduction, such as during dental work, have been demonstrated to make drug administration painless and well tolerated, making it an attractive potential alternative to commonly used intravenous and intramuscular approaches. In several small research studies, high doses of intranasal ketamine (9 mg/kg) produce adequate sedation during laceration repair with minimal side effects. A recent study compared IN ketamine, midazolam, fentanyl or combination of these drugs for pain management and urgent analgesia sedation, and demonstrated that they are effective and safe, reporting that ~60% of study participants sustained mild to moderate sedation. Unfortunately, there are not enough studies done to evaluate the sedation effect of IN ketamine for laceration repair. Small studies (Tsze and Nemeth) showed that IN ketamine is an effective alternative but no studies are done to compare combination IN midazolam and fentanyl to IN ketamine. Our null hypothesis is that there is no difference in sedation scores during laceration repair when comparing the use of IN ketamine to IN midazolam and IN fentanyl.

We will recruit a total of 30 pediatric patients (6 months - 10 y age) in a randomized double-blinded pilot study of IN ketamine alone or combined IN midazolam and IN fentanyl for laceration repair, comparing levels of pain and sedation scores using validated pediatric metrics as the primary outcomes. In addition, we will assess comparative nurse and physician satisfaction in each of these two groups. Understanding the relative effectiveness of these two approaches will help us identify a safe, effective, and easily administrable method to manage pain and anxiety, thereby, improving patient experience and outcomes during the often traumatic laceration repair procedure.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomized double blinded control trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
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.
Primary Purpose: Treatment
Condition  ICMJE Laceration of Skin
Intervention  ICMJE
  • Drug: Ketamine
    Intranasal ketamine 3mg/kg (max 100 mg) + saline 0.03 ml/kg (max 2ml)
  • Drug: Midazolam and fentanyl
    Intranasal midazolam 0.3 mg/kg (max 10 mg) + fentanyl 1.5mcg/kg (max 100 mcg)
Study Arms  ICMJE
  • Experimental: IN ketamine
    Intranasal ketamine 3mg/kg (max 100 mg) + saline 0.03 ml/kg (max 2ml)
    Intervention: Drug: Ketamine
  • Active Comparator: IN midazolam and fentanyl
    Intranasal midazolam 0.3 mg/kg (max 10 mg) + fentanyl 1.5mcg/kg (max 100 mcg)
    Intervention: Drug: Midazolam and fentanyl
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 5, 2018)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 15, 2021
Estimated Primary Completion Date February 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • General trauma requiring additional sedation
  • Patients who received pain medications (acetaminophen or ibuprofen) before laceration repair
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Months to 10 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ali Ozcan, MD 7187758031 ali.ozcan@beaumont.org
Contact: Mara Branoff, RN 2488981792 mara.branoff@beaumont.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03528512
Other Study ID Numbers  ICMJE 2017-363
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Kelly Levasseur, DO, William Beaumont Hospitals
Study Sponsor  ICMJE William Beaumont Hospitals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kelly Levasseur, DO William Beaumont Hospitals
PRS Account William Beaumont Hospitals
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP