Nausea/Vomiting, Pruritus
Conditions
Keywords
intrathecal morphine
Brief summary
This is a prospective randomized, double-blind, placebo-controlled study to compare the incidence and intensity of ITM-induced pruritus and nausea/vomiting using pre-emptive IV ondansetron, followed by scheduled Around The Clock (ATC) ondansetron vs. our control group, where pruritus and PONV are treated with PRN only medications.
Detailed description
Pruritus is one of the most common and bothersome side effects of intrathecal morphine (ITM) in children, with a reported incidence of 30-60%. Clinicians, who have witnessed unbearable itching and scratching in their young patients after intrathecal morphine, may be reluctant to offer this effective pain control to future patients, for fear of these unpleasant sequelae. A study previously found a 40% incidence of pruritus in young children who received intrathecal morphine for major urologic surgery. This is a prospective randomized, double-blind, placebo-controlled study to compare the incidence and intensity of ITM-induced pruritus and nausea/vomiting using pre-emptive IV ondansetron, followed by scheduled Around The Clock (ATC) ondansetron vs. control group, where pruritus and PONV are treated with PRN only medications. Enrollment of 3-17 year olds who are undergoing urologic or orthopedic operative procedures who are scheduled to receive low dose (4-5 mcg/kg) intrathecal morphine for pain management.
Interventions
DRUGOndansetron
This arm will receive (in a blinded fashion) 0.1 mg/kg of Ondansetron IV made up to 5 mLs intra-operatively and Ondansetron IV 0.1 mg/kg made up to 5 mLs every 6 hours for 24 hours postoperatively.
DRUGPlacebo Comparator
This arm will receive (in a blinded fashion) a volume-matched placebo intraoperatively as well as IV every 6 hrs for 24 hours postoperatively.
Sponsors
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Study drug (ondansetron/placebo) will be masked for all but the pharmacist
Intervention model description
Randomized, double blinded, placebo-controlled trial of ondansetron to prevent pruritus in children who receive intrathecal morphine
Eligibility
Sex/Gender
ALL
Age
3 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* 3-17 years * weight \</= 100kg * scheduled for urologic or orthopedic procedure necessitating intrathecal morphine * ability to use verbal or pictorial pain assessment tools and techniques * informed consent and (if applicable) assent
Exclusion criteria
* Inability to use verbal or pictorial pain scoring scales * hypersensitivity to selective 5-HT receptor antagonists * diagnosed congenital long QT syndrome * severe hepatic impairment * pregnancy or nursing mothers
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Pruritus | 24 hours | number of participants with any incidence of pruritus |
| Severity of Pruritus | 24 hours | number of participants who indicated mild pruritus (no treatment needed) or severe pruritus (treatment needed) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Post Operative Nausea or Vomiting | 24 hours | number of participants with any incidence of postoperative nausea or vomiting |
| Severity of Post Operative Nausea or Vomiting | 24 hours | number of participants who Indicated mild post operative nausea or vomiting (no treatment needed) or severe postoperative nausea or vomiting(treatment needed) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ondansetron IV Ondansetron IV X1 intraoperatively (0.1 mg/kg in 5 mLs) Ondansetron IV X 4 (Q 6 hrs for 24 hrs) (0.1 mg/kg in 5 mLs)
Ondansetron: This arm will receive (in a blinded fashion) 0.1 mg/kg of Ondansetron IV made up to 5 mLs intra-operatively and Ondansetron IV 0.1 mg/kg made up to 5 mLs every 6 hours for 24 hours postoperatively. | 18 |
| Placebo Placebo Comparator: This arm will receive (in a blinded fashion) a volume-matched placebo intraoperatively X1 as well as IV every 6 hrs for 24 hours postoperatively. (X4)
Placebo Comparator: This arm will receive (in a blinded fashion) a volume-matched placebo intraoperatively as well as IV every 6 hrs for 24 hours postoperatively. | 27 |
| Total | 45 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Ondansetron IV | Placebo | Total |
|---|---|---|---|
| Age, Customized | 8.3 years | 8.2 years | 8.3 years |
| ASA 1, 2 | 15 Participants | 27 Participants | 42 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 12 Participants | 17 Participants | 29 Participants |
| Sex: Female, Male Male | 6 Participants | 10 Participants | 16 Participants |
| Surgical Service Orthopedics | 4 Participants | 5 Participants | 9 Participants |
| Surgical Service Urology | 14 Participants | 22 Participants | 36 Participants |
| Weight | 30.4 kg | 34.0 kg | 32.5 kg |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 27 |
| other Total, other adverse events | 0 / 18 | 0 / 27 |
| serious Total, serious adverse events | 0 / 18 | 0 / 27 |
Outcome results
Primary
Incidence of Pruritus
number of participants with any incidence of pruritus
Time frame: 24 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ondansetron IV | Incidence of Pruritus | 14 Participants |
| Placebo | Incidence of Pruritus | 24 Participants |
p-value: 0.412Chi-squared
Primary
Severity of Pruritus
number of participants who indicated mild pruritus (no treatment needed) or severe pruritus (treatment needed)
Time frame: 24 hours
Population: Excludes those without any itch
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ondansetron IV | Severity of Pruritus | Severe / requiring treatment | 13 Participants |
| Ondansetron IV | Severity of Pruritus | Mild / no treatment needed | 1 Participants |
| Placebo | Severity of Pruritus | Severe / requiring treatment | 20 Participants |
| Placebo | Severity of Pruritus | Mild / no treatment needed | 4 Participants |
p-value: 0.633Chi-squared
Secondary
Incidence of Post Operative Nausea or Vomiting
number of participants with any incidence of postoperative nausea or vomiting
Time frame: 24 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ondansetron IV | Incidence of Post Operative Nausea or Vomiting | 8 Participants |
| Placebo | Incidence of Post Operative Nausea or Vomiting | 23 Participants |
p-value: 0.007Chi-squared
Secondary
Severity of Post Operative Nausea or Vomiting
number of participants who Indicated mild post operative nausea or vomiting (no treatment needed) or severe postoperative nausea or vomiting(treatment needed)
Time frame: 24 hours
Population: excludes those without any nausea vomiting
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ondansetron IV | Severity of Post Operative Nausea or Vomiting | Mild / no treatment required | 2 Participants |
| Ondansetron IV | Severity of Post Operative Nausea or Vomiting | Severe / requiring treatment | 6 Participants |
| Placebo | Severity of Post Operative Nausea or Vomiting | Mild / no treatment required | 4 Participants |
| Placebo | Severity of Post Operative Nausea or Vomiting | Severe / requiring treatment | 19 Participants |
p-value: 0.634Chi-squared