Pain, Postoperative, Postoperative Nausea and Vomiting, Scoliosis
Conditions
Keywords
Narcotic Antagonists, Naloxone infusion, Postoperative pruritis, Patient controlled analgesia, Pediatric, Children
Brief summary
There will be two groups in this study: one group will be given the standard infusion of naloxone, a drug which helps reduce side effects from opioids needed after surgery, and the other group will receive a higher dose. The trial is designed to determine if a higher dose of naloxone infusion will reduce side effects from opioid therapy in patients who have undergone spine fusion for scoliosis.
Detailed description
Currently, patients undergoing spinal fusion for scoliosis are routinely given patient controlled analgesia (PCA) for pain control postoperatively. PCA therapy is typically combined with an ultra low dose naloxone infusion because of the established benefit of reduced pruritis and nausea. The investigators hypothesize that using a higher dose naloxone infusion may lead to further improvement in pruritis and nausea and may improve GI function. Improvement in bowel function could lead to faster initiation of oral intake as well as transition to oral pain medication and even decreased length of stay.
Interventions
DRUGNaloxone
Naloxone infusion 0.5 mcg/kg/hr
Sponsors
Children's Mercy Hospital Kansas City
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
10 Years to 21 Years
Healthy volunteers
No
Inclusion criteria
* Idiopathic scoliosis requiring spine fusion surgery * Age 10-21 years
Exclusion criteria
* Inability to understand PCA instructions * Allergy to: morphine, hydromorphone, fentanyl, naloxone, or diphenhydramine * Chronic opioid therapy \> 2 months * Non-English speaking
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Hours Until Tolerating Oral Intake | Assessed daily in hospital while in hospital until taking orals, average 4 days. | Defined as time when awakening after surgery until tolerating orals. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Severity of Itching | Assessed daily while in hospital requiring PCA | Visual analog scale presented to subject to complete daily. Minimum value 0 none to maximum value 10 worst possible. Higher scores represent worse outcome. Title of scale Itching VAS. Scores were assessed daily for 5 days and an average of the five days was reported. |
| Severity of Nausea | Assessed daily while in hospital requiring PCA. | Nausea VAS presented to subject daily. Zero minimum none to 10 maximum worse possible. Higher scores represent worse clinical outcome. Name of scale Nausea VAS. Scores were assessed daily for 5 days and an average of the five days reported. |
| Severity of Pain | Assessed by bedside nurse 3 times daily while requiring PCA | Visual analog scale for pain. Zero none minimum to 10 worse possible maximum. Name of scale Pain VAS. Scores were assessed daily for 5 days and an average of the five days was reported. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Naloxone Infusion 0.5 mcg/kg/hr Naloxone: Naloxone infusion 0.5 mcg/kg/hr | 37 |
| Naloxone 2.5 mcg/kg/hr Naloxone infusion 2.5 mcg/kg/hr
Naloxone: Naloxone infusion 2.5 mcg/kg/hr | 42 |
| Total | 79 |
Baseline characteristics
| Characteristic | Naloxone Infusion 0.5 mcg/kg/hr | Naloxone 2.5 mcg/kg/hr | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 37 Participants | 42 Participants | 79 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 37 participants | 41 participants | 78 participants |
| Sex: Female, Male Female | 34 Participants | 37 Participants | 71 Participants |
| Sex: Female, Male Male | 3 Participants | 5 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 37 | 0 / 42 |
| other Total, other adverse events | 0 / 37 | 0 / 42 |
| serious Total, serious adverse events | 0 / 37 | 0 / 42 |
Outcome results
Primary
Number of Hours Until Tolerating Oral Intake
Defined as time when awakening after surgery until tolerating orals.
Time frame: Assessed daily in hospital while in hospital until taking orals, average 4 days.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Naloxone Infusion 0.5 mcg/kg/hr | Number of Hours Until Tolerating Oral Intake | 25.9 hours |
| Naloxone 2.5 mcg/kg/hr | Number of Hours Until Tolerating Oral Intake | 25.0 hours |
Secondary
Severity of Itching
Visual analog scale presented to subject to complete daily. Minimum value 0 none to maximum value 10 worst possible. Higher scores represent worse outcome. Title of scale Itching VAS. Scores were assessed daily for 5 days and an average of the five days was reported.
Time frame: Assessed daily while in hospital requiring PCA
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Naloxone Infusion 0.5 mcg/kg/hr | Severity of Itching | 2.1 score on a scale, averaged |
| Naloxone 2.5 mcg/kg/hr | Severity of Itching | 1.9 score on a scale, averaged |
Secondary
Severity of Nausea
Nausea VAS presented to subject daily. Zero minimum none to 10 maximum worse possible. Higher scores represent worse clinical outcome. Name of scale Nausea VAS. Scores were assessed daily for 5 days and an average of the five days reported.
Time frame: Assessed daily while in hospital requiring PCA.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Naloxone Infusion 0.5 mcg/kg/hr | Severity of Nausea | 2.0 score on a scale, averaged |
| Naloxone 2.5 mcg/kg/hr | Severity of Nausea | 1.2 score on a scale, averaged |
Secondary
Severity of Pain
Visual analog scale for pain. Zero none minimum to 10 worse possible maximum. Name of scale Pain VAS. Scores were assessed daily for 5 days and an average of the five days was reported.
Time frame: Assessed by bedside nurse 3 times daily while requiring PCA
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Naloxone Infusion 0.5 mcg/kg/hr | Severity of Pain | 3.7 units on a scale, averaged |
| Naloxone 2.5 mcg/kg/hr | Severity of Pain | 4.1 units on a scale, averaged |