MedDataX Logo

Trial Outcomes & Findings for Emergency Department (ED) Drug Interaction in Emergency Department Patients (NCT NCT01859715)

NCT ID: NCT01859715

Last Updated: 2016-05-05

Results Overview

Clinically significant visual analogue scale (VAS; a measure of adult pain and nausea on a scale of 1-100 millimeters for increasing symptoms of pain and nausea) for patients who were administered either oxycodone, hydrocodone/acetaminophen, or ondansetron in the ED. Clinically significant change was defined as 13mm change on the VAS from baseline (when first VAS was completed) to 90 minutes following drug administration in the ED.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

502 participants

Primary outcome timeframe

Baseline and 90 minutes

Results posted on

2016-05-05

Participant Flow

Recruitment was initiated in the University of Colorado Hospital ED. A convenience sample sample of ED patients were enrolled between June 2012 to January 2013. Subjects were included if they had self-reported pain or nausea identified during the initial nursing assessment. The previous 2 day medication history was obtained during their visit.

201/502 consented patients did not receive the study medication. The remaining 301 patients were allocated to either one of the opioid treatment groups or the nausea observational group based on what study medication they were prescribed and if they were able to complete serial visual analog scales for pain and nausea.

Participant milestones

Participant milestones
Measure
Oxycodone Group
Subjects given oxycodone 5mg by ED provider decision or by triage nurse randomization.
Hydrocodone/Acetaminophen Group
Subjects given hydrocodone/acetaminophen 5mg/500mg by ED provider decision or by triage nurse randomization.
Nausea-observational Group
Patients given ondansetron 4mg for reported nausea or vomiting by ED provider decision or by triage nurse. This is an observational cohort only.
Overall Study
STARTED
141
91
116
Overall Study
COMPLETED
125
83
93
Overall Study
NOT COMPLETED
16
8
23

Reasons for withdrawal

Reasons for withdrawal
Measure
Oxycodone Group
Subjects given oxycodone 5mg by ED provider decision or by triage nurse randomization.
Hydrocodone/Acetaminophen Group
Subjects given hydrocodone/acetaminophen 5mg/500mg by ED provider decision or by triage nurse randomization.
Nausea-observational Group
Patients given ondansetron 4mg for reported nausea or vomiting by ED provider decision or by triage nurse. This is an observational cohort only.
Overall Study
No 2nd VAS
16
8
23

Baseline Characteristics

Emergency Department (ED) Drug Interaction in Emergency Department Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Oxycodone Group
n=141 Participants
Subjects given oxycodone 5mg by ED provider decision or by triage nurse randomization.
Hydrocodone/Acetaminophen Group
n=91 Participants
Subjects given hydrocodone/acetaminophen 5mg/500 mg by ED provider decision or by triage nurse randomization.
Nausea-observational Group
n=116 Participants
Patients given ondansetron for reported nausea or vomiting by ED provider decision or by triage nurse. This is an observational cohort only.
Total
n=348 Participants
Total of all reporting groups
Age, Continuous
40 years
n=5 Participants
38 years
n=7 Participants
34 years
n=5 Participants
40 years
n=4 Participants
Sex: Female, Male
Female
79 Participants
n=5 Participants
56 Participants
n=7 Participants
83 Participants
n=5 Participants
218 Participants
n=4 Participants
Sex: Female, Male
Male
62 Participants
n=5 Participants
35 Participants
n=7 Participants
33 Participants
n=5 Participants
130 Participants
n=4 Participants
Number of CYP2D6 drugs taken
1 CYP2D6 drug
n=5 Participants
1 CYP2D6 drug
n=7 Participants
1 CYP2D6 drug
n=5 Participants
1 CYP2D6 drug
n=4 Participants

PRIMARY outcome

Timeframe: Baseline and 90 minutes

Clinically significant visual analogue scale (VAS; a measure of adult pain and nausea on a scale of 1-100 millimeters for increasing symptoms of pain and nausea) for patients who were administered either oxycodone, hydrocodone/acetaminophen, or ondansetron in the ED. Clinically significant change was defined as 13mm change on the VAS from baseline (when first VAS was completed) to 90 minutes following drug administration in the ED.

Outcome measures

Outcome measures
Measure
Oxycodone Group
n=125 Participants
Subjects given oxycodone 5mg mg by ED provider decision or by triage nurse randomization.
Hydrocodone/Acetaminophen Group
n=83 Participants
Subjects given or hydrocodone/acetaminophen 5mg/500mg by ED provider decision or by triage nurse randomization.
Nausea-observational Group
n=93 Participants
Patients given ondansetron 4mg for reported nausea or vomiting by ED provider decision or by triage nurse. This is an observational cohort only.
Difference in Clinically Significant Visual Analogue Scale for Pain and Nausea Change Between CYP2D6 Users and Non-users
7.4 millimeters
Interval -0.8 to 15.6
10.9 millimeters
Interval 0.8 to 21.1
-14.0 millimeters
Interval -23.6 to -4.4

SECONDARY outcome

Timeframe: Duration of ED stay, <24 hours. (up to 24 hours)

Determine all possible adverse drug events that occurred after the study drugs were administered.

Outcome measures

Outcome measures
Measure
Oxycodone Group
n=125 Participants
Subjects given oxycodone 5mg mg by ED provider decision or by triage nurse randomization.
Hydrocodone/Acetaminophen Group
n=83 Participants
Subjects given or hydrocodone/acetaminophen 5mg/500mg by ED provider decision or by triage nurse randomization.
Nausea-observational Group
n=93 Participants
Patients given ondansetron 4mg for reported nausea or vomiting by ED provider decision or by triage nurse. This is an observational cohort only.
Adverse Drug Events
0 participants
0 participants
0 participants

Adverse Events

Oxycodone Group

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Hydrocodone/Acetaminophen Group

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Nausea-observational Group

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

Andrew A Monte, MD

University of Colorado

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place