IN Ketamine vs IN Midazolam and Fentanyl for Laceration Repair

NCT ID: NCT03528512

Last Updated: 2021-08-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-04
• Study Completion Date: 2019-02-06

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.

Conditions

Laceration of Skin

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

IN ketamine

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

Group Type: EXPERIMENTAL

Ketamine

Intervention Type: DRUG

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

IN midazolam and fentanyl

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

Group Type: ACTIVE_COMPARATOR

Midazolam and fentanyl

Intervention Type: DRUG

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

Interventions

Ketamine

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

Intervention Type: DRUG

Midazolam and fentanyl

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

William Beaumont Hospitals

OTHER

Sponsor Role: lead

Responsible Party

Margaret J Menoch, MD

Pediatric ER Medical Clinical Faculty

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kelly Levasseur, DO

Role: PRINCIPAL_INVESTIGATOR

William Beaumont Hospitals

Locations

Beaumont Hospital - Royal Oak

Royal Oak, Michigan, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2017-363

Identifier Type: -

Identifier Source: org_study_id