Trial Outcomes & Findings for Does a Non-Opioid Multimodal Pain (NOMO) Protocol Decrease Narcotic Use (NCT NCT05386069)
NCT ID: NCT05386069
Last Updated: 2025-05-23
Results Overview
Total morphine milligram equivalents calculated for each patient during their stay.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
10 participants
Primary outcome timeframe
from immediately postoperative through discharge or 4 weeks, whichever comes first
Results posted on
2025-05-23
Participant Flow
Participant milestones
| Measure |
Control Arm
Routine Care per Anesthiologist/cRNA
|
Treatment Arm
Patients to receive standard weight-based ketamine bolus (0.5 mg/kg) at start of procedure, withhold opioids in post-operative period unless rescue medications fail
NOMO Protocol: Standard weight-based ketamine bolus (0.5 mg/kg) at procedure start, no Opioid rescue medications
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
|
Overall Study
COMPLETED
|
5
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Does a Non-Opioid Multimodal Pain (NOMO) Protocol Decrease Narcotic Use
Baseline characteristics by cohort
| Measure |
Control Arm
n=5 Participants
Routine Care per Anesthiologist/cRNA
|
Treatment Arm
n=5 Participants
Patients to receive standard weight-based ketamine bolus (0.5 mg/kg) at start of procedure, withhold opioids in post-operative period unless rescue medications fail
NOMO Protocol: Standard weight-based ketamine bolus (0.5 mg/kg) at procedure start, no Opioid rescue medications
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Brief Pain Inventory (Short Form)
|
4.8 units on a scale
n=5 Participants
|
2.4 units on a scale
n=7 Participants
|
3.6 units on a scale
n=5 Participants
|
PRIMARY outcome
Timeframe: from immediately postoperative through discharge or 4 weeks, whichever comes firstPopulation: Patients undergoing urogynecologic procedure.
Total morphine milligram equivalents calculated for each patient during their stay.
Outcome measures
| Measure |
Control Arm
n=5 Participants
Routine Care per Anesthiologist/cRNA
|
Treatment Arm
n=5 Participants
Patients to receive standard weight-based ketamine bolus (0.5 mg/kg) at start of procedure, withhold opioids in post-operative period unless rescue medications fail
NOMO Protocol: Standard weight-based ketamine bolus (0.5 mg/kg) at procedure start, no Opioid rescue medications
|
|---|---|---|
|
Morphine Milligram Equivalents Used During Inpatient Stay
|
10.8 morhpine milligram equivalents
Standard Deviation 5.6
|
8.8 morhpine milligram equivalents
Standard Deviation 7.1
|
SECONDARY outcome
Timeframe: from immediately postoperative through discharge or 4 weeks, whichever comes firstpercentage of patients who pass voiding trial on POD#1
Outcome measures
| Measure |
Control Arm
n=5 Participants
Routine Care per Anesthiologist/cRNA
|
Treatment Arm
n=5 Participants
Patients to receive standard weight-based ketamine bolus (0.5 mg/kg) at start of procedure, withhold opioids in post-operative period unless rescue medications fail
NOMO Protocol: Standard weight-based ketamine bolus (0.5 mg/kg) at procedure start, no Opioid rescue medications
|
|---|---|---|
|
Passage of Voiding Trial
|
4 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: postoperative day 1 through day of discharge from hospital; all patients were dischard on post-op day 1Did the patient require anti-emetics in the post-operative period
Outcome measures
| Measure |
Control Arm
n=5 Participants
Routine Care per Anesthiologist/cRNA
|
Treatment Arm
n=5 Participants
Patients to receive standard weight-based ketamine bolus (0.5 mg/kg) at start of procedure, withhold opioids in post-operative period unless rescue medications fail
NOMO Protocol: Standard weight-based ketamine bolus (0.5 mg/kg) at procedure start, no Opioid rescue medications
|
|---|---|---|
|
Anti-emetic Use
|
5 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: postoperative day 7Evaluated via the "Brief Pain Inventory (Short Form)"; rate pain on scale 0-10, 10 being worst
Outcome measures
| Measure |
Control Arm
n=5 Participants
Routine Care per Anesthiologist/cRNA
|
Treatment Arm
n=5 Participants
Patients to receive standard weight-based ketamine bolus (0.5 mg/kg) at start of procedure, withhold opioids in post-operative period unless rescue medications fail
NOMO Protocol: Standard weight-based ketamine bolus (0.5 mg/kg) at procedure start, no Opioid rescue medications
|
|---|---|---|
|
Patient Pain Score
|
4.8 score on a scale
Interval 0.0 to 10.0
|
2.4 score on a scale
Interval 0.0 to 10.0
|
SECONDARY outcome
Timeframe: postoperative day 2 through postoperative day 7Did the patient require a narcotic prescription
Outcome measures
| Measure |
Control Arm
n=5 Participants
Routine Care per Anesthiologist/cRNA
|
Treatment Arm
n=5 Participants
Patients to receive standard weight-based ketamine bolus (0.5 mg/kg) at start of procedure, withhold opioids in post-operative period unless rescue medications fail
NOMO Protocol: Standard weight-based ketamine bolus (0.5 mg/kg) at procedure start, no Opioid rescue medications
|
|---|---|---|
|
Prescription for Opioid at Discharge
|
4 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: postoperative day 1 through discharge or 4 weeks, whichever comes firstPopulation: All enrolled patients included - all patients stayed in hospital for 2 days.
The average number of days patients were admitted as inpatient.
Outcome measures
| Measure |
Control Arm
n=5 Participants
Routine Care per Anesthiologist/cRNA
|
Treatment Arm
n=5 Participants
Patients to receive standard weight-based ketamine bolus (0.5 mg/kg) at start of procedure, withhold opioids in post-operative period unless rescue medications fail
NOMO Protocol: Standard weight-based ketamine bolus (0.5 mg/kg) at procedure start, no Opioid rescue medications
|
|---|---|---|
|
Length of Hospital Stay
|
2 days
Interval 2.0 to 2.0
|
2 days
Interval 2.0 to 2.0
|
Adverse Events
Control Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Treatment Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place