Trial Outcomes & Findings for Relieving Acute Pain (RAP) Study: A Pilot Study (NCT NCT03426137)
NCT ID: NCT03426137
Last Updated: 2021-04-27
Results Overview
Collected on a visual analogue scale, with 0 being "no pain" and 100 being "maximum pain tolerable"
TERMINATED
PHASE2
3 participants
Day 1-7, Week 2, Months 1, 3 and 6
2021-04-27
Participant Flow
Three participants were consented from University of Maryland Shock Trauma Center, per protocol, between 3/17/2019 to 3/30/2019. All three withdrew before randomization or starting any study procedures.
Participant milestones
| Measure |
Full Dose (FD)
Participants in the FD arm will receive NSAIDs and Oxycodone (5mg).dosed in accordance with the Guidelines for Use from University of Maryland Shock Trauma Center.
Oxycodone: 5mg Oxycodone in oral solution given every 3 hours
Ketorolac: toradol intravenous (IV) 30mg. Maintain toradol IV every 8 hours, round the clock. For patients with renal insufficiency, decrease toradol dose to 15mg every 8 hours. For patients over 65 years old, decrease toradol dose to 15 mg every 8 hours. After 24 hours, start oral NSAIDS every 8 hours round the clock when tolerating pain.
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PR (Partial Reinforcement)
Participants in this group will receive NSAIDs, Oxycodone (5mg), and placebo pills to reach a 50% reduction of the total intake of opioids.
Oxycodone: 5mg Oxycodone in oral solution given every 3 hours
Ketorolac: toradol intravenous (IV) 30mg. Maintain toradol IV every 8 hours, round the clock. For patients with renal insufficiency, decrease toradol dose to 15mg every 8 hours. For patients over 65 years old, decrease toradol dose to 15 mg every 8 hours. After 24 hours, start oral NSAIDS every 8 hours round the clock when tolerating pain.
Placebo: Oral solutions containing only the carrier vehicle - a flavored syrup called OraSweet
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C (Control)
Participants in this group will receive NSAIDs and placebo pills
Ketorolac: toradol intravenous (IV) 30mg. Maintain toradol IV every 8 hours, round the clock. For patients with renal insufficiency, decrease toradol dose to 15mg every 8 hours. For patients over 65 years old, decrease toradol dose to 15 mg every 8 hours. After 24 hours, start oral NSAIDS every 8 hours round the clock when tolerating pain.
Placebo: Oral solutions containing only the carrier vehicle - a flavored syrup called OraSweet
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Overall Study
STARTED
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0
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0
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0
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Overall Study
COMPLETED
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0
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0
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0
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Overall Study
NOT COMPLETED
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0
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0
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Relieving Acute Pain (RAP) Study: A Pilot Study
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: Day 1-7, Week 2, Months 1, 3 and 6Population: All three participants gave written consent to participate in the study and signed the HIPAA form, but withdrew before starting any study procedures. These 3 withdrawals were handled per protocol. As is written in the consent, "You are free to withdraw your consent at any time." Therefore, there was no analyzable data collected.
Collected on a visual analogue scale, with 0 being "no pain" and 100 being "maximum pain tolerable"
Outcome measures
Outcome data not reported
Adverse Events
Full Dose (FD)
PR (Partial Reinforcement)
C (Control)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Research Coordinator
University of Maryland School of Nursing
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place