A Phase 4 interventional study of Ketamine and Midazolam and fentanyl in Laceration of Skin, sponsored by William Beaumont Hospitals. Terminated at 1 site in United States. Open to participants aged 6 Months to 10 Years. Per ClinicalTrials.gov, last updated 2021-08-24.
Sponsored by William Beaumont Hospitals · Phase 4, Interventional, and Treatment
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.
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.
133 studies on the registry are indexed under Lacerations; 29 are open to participants now.
This study's enrollment of 5 is below the median of 79 across 106 interventional studies indexed under Lacerations.
Browse Lacerations studies →William Beaumont Hospitals is the lead sponsor of 111 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Intranasal ketamine 3mg/kg (max 100 mg) + saline 0.03 ml/kg (max 2ml)
Drug: Ketamine
Intranasal midazolam 0.3 mg/kg (max 10 mg) + fentanyl 1.5mcg/kg (max 100 mcg)
Drug: Midazolam and fentanyl
Intranasal ketamine 3mg/kg (max 100 mg) + saline 0.03 ml/kg (max 2ml)
Intranasal midazolam 0.3 mg/kg (max 10 mg) + fentanyl 1.5mcg/kg (max 100 mcg)
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.
Time frame: 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)
Time frame: Up to 30 minutes
Pain Scores During Laceration Repair
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
Time frame: Up to 30 minutes
Nurse and Physician Satisfaction
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.
Time frame: Up to 30 minutes
Rates of Failure
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.
Time frame: Up to 30 minutes
Change in Vitals
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.
Time frame: up to 30 minutes
| Milestone | IN Ketamine | IN Midazolam and Fentanyl |
|---|---|---|
| Started | 3 | 2 |
| Completed | 3 | 2 |
| Not completed | 0 | 0 |
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.
| units on a scale | IN Ketamine | IN Midazolam and Fentanyl |
|---|---|---|
| Sedation Score | 1 (.5 to 1) | 1 (1 to 1) |
The proportion of children who receive a maximum sedation score of either 1 or 2 (without distinguishing between those values)
| Participants | IN Ketamine | IN Midazolam and Fentanyl |
|---|---|---|
| Proportion of Children With Maximum Sedation Score | 2 | 2 |
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
| units on a scale | IN Ketamine | IN Midazolam and Fentanyl |
|---|---|---|
| Pain Scores During Laceration Repair | 4 (4 to 4.5) | 0 (0 to 0) |
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.
| Participants | IN Ketamine | IN Midazolam and Fentanyl |
|---|---|---|
| Nurse and Physician Satisfaction | 1 | 4 |
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.
| Participants | IN Ketamine | IN Midazolam and Fentanyl |
|---|---|---|
| Rates of Failure | 0 | 0 |
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.
| Participants | IN Ketamine | IN Midazolam and Fentanyl |
|---|---|---|
| Change in Vitals | 0 | 0 |
Collected over 30-45 minutes. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| IN Ketamine | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) |
| IN Midazolam and Fentanyl | 0/2 (0%) | 0/2 (0%) | 0/2 (0%) |
| Age, Continuous(years) | IN Ketamine | IN Midazolam and Fentanyl | Total |
|---|---|---|---|
| Mean | 2 ± 0.87 | 2 ± 0 | 2 ± 0.61 |
| Sex: Female, Male(Participants) | IN Ketamine | IN Midazolam and Fentanyl | Total |
|---|---|---|---|
| Female | 0 | 2 | 2 |
| Male | 3 | 0 | 3 |
| Race (NIH/OMB)(Participants) | IN Ketamine | IN Midazolam and Fentanyl | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 2 | 1 | 3 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 1 | 2 |
| Region of Enrollment(participants) | IN Ketamine | IN Midazolam and Fentanyl | Total |
|---|---|---|---|
| United States | 3 | 2 | 5 |
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William Beaumont Hospitals