Trial Outcomes & Findings for Acetaminophen's Efficacy For Post-operative Pain (NCT NCT01721486)
NCT ID: NCT01721486
Last Updated: 2017-06-08
Results Overview
All pain medication documented during the first 24 hours postoperatively, in mg morphine equivalents.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
41 participants
Primary outcome timeframe
From time of PACU admission until 24 hours post-operatively.
Results posted on
2017-06-08
Participant Flow
Participants were enrolled over a period of 23 months in the pre-operative setting of an out-patient surgical unit.
Participant milestones
| Measure |
Study Group
IV acetaminophen 15 mg/kg (up to 1000 mg) administered intraoperatively over a 15 minute infusion.
IV acetaminophen: IV acetaminophen 15 mg/kg (up to 1000 mg) over 15 minute infusion after IV placement in OR in study group only.
|
Control Group
PO acetaminophen elixir 15 mg/kg (up to 1000 mg) administered approximately 90 minutes (+/- 30 minutes) prior to induction of anesthesia in the pre-operative area.
PO acetaminophen: PO acetaminophen elixir 15 mg/kg (up to 1000 mg) administered approximately 90 minutes (+/- 30minutes) prior to induction of anesthesia in the pre-operative area.
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
20
|
|
Overall Study
COMPLETED
|
20
|
19
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Study Group
IV acetaminophen 15 mg/kg (up to 1000 mg) administered intraoperatively over a 15 minute infusion.
IV acetaminophen: IV acetaminophen 15 mg/kg (up to 1000 mg) over 15 minute infusion after IV placement in OR in study group only.
|
Control Group
PO acetaminophen elixir 15 mg/kg (up to 1000 mg) administered approximately 90 minutes (+/- 30 minutes) prior to induction of anesthesia in the pre-operative area.
PO acetaminophen: PO acetaminophen elixir 15 mg/kg (up to 1000 mg) administered approximately 90 minutes (+/- 30minutes) prior to induction of anesthesia in the pre-operative area.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Physician Decision
|
0
|
1
|
Baseline Characteristics
Acetaminophen's Efficacy For Post-operative Pain
Baseline characteristics by cohort
| Measure |
Study Group
n=20 Participants
IV acetaminophen 15 mg/kg (up to 1000 mg) administered intraoperatively over a 15 minute infusion.
IV acetaminophen: IV acetaminophen 15 mg/kg (up to 1000 mg) over 15 minute infusion after IV placement in OR in study group only.
|
Control Group
n=19 Participants
PO acetaminophen elixir 15 mg/kg (up to 1000 mg) administered approximately 90 minutes (+/- 30 minutes) prior to induction of anesthesia in the pre-operative area.
PO acetaminophen: PO acetaminophen elixir 15 mg/kg (up to 1000 mg) administered approximately 90 minutes (+/- 30minutes) prior to induction of anesthesia in the pre-operative area.
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
20 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From time of PACU admission until 24 hours post-operatively.Population: Only patients receiving rescue pain medication were analyzed.
All pain medication documented during the first 24 hours postoperatively, in mg morphine equivalents.
Outcome measures
| Measure |
Study Group
n=14 Participants
IV acetaminophen 15 mg/kg (up to 1000 mg) administered intraoperatively over a 15 minute infusion after IV placement in OR in study group only.
|
Control Group
n=14 Participants
PO acetaminophen elixir 15 mg/kg (up to 1000 mg) administered approximately 90 minutes (+/- 30 minutes) prior to induction of anesthesia in the pre-operative area.
|
|---|---|---|
|
Total Pain Medication
|
1.7 mg
Interval 0.0 to 5.5
|
2.2 mg
Interval 0.0 to 4.5
|
SECONDARY outcome
Timeframe: At time of admission into PACU.FLACC: Face, Legs, Activity, Cry, and Consolability Pain Assessment Scale (FLACC), a five-item, three point scale that measures each of 5 pain behaviors on a scale of 0 - 2 which are summed to result in a total score of 0 - 10. Clinical judgment is used to interpret pain. The higher the score on the FLACC correlates with a higher pain score (0= no behaviors indicative of pain and 10= five behaviors indicative of significant pain). This scale was evaluated by blinded post-operative anesthesia care unit (PACU) Registered Nurses (RNs) at admission to PACU.
Outcome measures
| Measure |
Study Group
n=20 Participants
IV acetaminophen 15 mg/kg (up to 1000 mg) administered intraoperatively over a 15 minute infusion after IV placement in OR in study group only.
|
Control Group
n=19 Participants
PO acetaminophen elixir 15 mg/kg (up to 1000 mg) administered approximately 90 minutes (+/- 30 minutes) prior to induction of anesthesia in the pre-operative area.
|
|---|---|---|
|
FLACC: Face, Legs, Activity, Cry & Consolability (FLACC) Pain Assessment Scores
|
0 units on a scale
Interval 0.0 to 10.0
|
0 units on a scale
Interval 0.0 to 8.0
|
SECONDARY outcome
Timeframe: From admission into PACU until 24 hours post-hospital discharge. At the conclusion of enrollment, this measure will be assessed for all participants.Percentage of subjects with at least one episode of post-operative vomiting
Outcome measures
| Measure |
Study Group
n=20 Participants
IV acetaminophen 15 mg/kg (up to 1000 mg) administered intraoperatively over a 15 minute infusion after IV placement in OR in study group only.
|
Control Group
n=19 Participants
PO acetaminophen elixir 15 mg/kg (up to 1000 mg) administered approximately 90 minutes (+/- 30 minutes) prior to induction of anesthesia in the pre-operative area.
|
|---|---|---|
|
Incidence of Post-operative Vomiting
|
1 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 24 hours post hospital discharge.Parental satisfaction with pain control, as measured on a 10 point Likert scale where 1= Extremely dissatisfied and 10= Extremely satisfied. Data gathered through phone call to parents 24 hours post hospital discharge.
Outcome measures
| Measure |
Study Group
n=20 Participants
IV acetaminophen 15 mg/kg (up to 1000 mg) administered intraoperatively over a 15 minute infusion after IV placement in OR in study group only.
|
Control Group
n=19 Participants
PO acetaminophen elixir 15 mg/kg (up to 1000 mg) administered approximately 90 minutes (+/- 30 minutes) prior to induction of anesthesia in the pre-operative area.
|
|---|---|---|
|
Parental Satisfaction With Pain Control.
|
9 units on a scale
Interval 8.0 to 10.0
|
8 units on a scale
Interval 8.0 to 10.0
|
Adverse Events
Study Group
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Control Group
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Study Group
n=20 participants at risk
IV acetaminophen 15 mg/kg (up to 1000 mg) administered intraoperatively over a 15 minute infusion.
IV acetaminophen: IV acetaminophen 15 mg/kg (up to 1000 mg) over 15 minute infusion after IV placement in OR in study group only.
|
Control Group
n=19 participants at risk
PO acetaminophen elixir 15 mg/kg (up to 1000 mg) administered approximately 90 minutes (+/- 30 minutes) prior to induction of anesthesia in the pre-operative area.
PO acetaminophen: PO acetaminophen elixir 15 mg/kg (up to 1000 mg) administered approximately 90 minutes (+/- 30minutes) prior to induction of anesthesia in the pre-operative area.
|
|---|---|---|
|
Blood and lymphatic system disorders
bleeding
|
0.00%
0/20 • Adverse events were collected after informed consent was obtained until the follow-up telephone call 24 hours following hospital discharge.
|
5.3%
1/19 • Adverse events were collected after informed consent was obtained until the follow-up telephone call 24 hours following hospital discharge.
|
Other adverse events
| Measure |
Study Group
n=20 participants at risk
IV acetaminophen 15 mg/kg (up to 1000 mg) administered intraoperatively over a 15 minute infusion.
IV acetaminophen: IV acetaminophen 15 mg/kg (up to 1000 mg) over 15 minute infusion after IV placement in OR in study group only.
|
Control Group
n=19 participants at risk
PO acetaminophen elixir 15 mg/kg (up to 1000 mg) administered approximately 90 minutes (+/- 30 minutes) prior to induction of anesthesia in the pre-operative area.
PO acetaminophen: PO acetaminophen elixir 15 mg/kg (up to 1000 mg) administered approximately 90 minutes (+/- 30minutes) prior to induction of anesthesia in the pre-operative area.
|
|---|---|---|
|
Nervous system disorders
nausea
|
0.00%
0/20 • Adverse events were collected after informed consent was obtained until the follow-up telephone call 24 hours following hospital discharge.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected after informed consent was obtained until the follow-up telephone call 24 hours following hospital discharge.
|
|
Gastrointestinal disorders
vomit x1
|
5.0%
1/20 • Number of events 1 • Adverse events were collected after informed consent was obtained until the follow-up telephone call 24 hours following hospital discharge.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected after informed consent was obtained until the follow-up telephone call 24 hours following hospital discharge.
|
|
Gastrointestinal disorders
vomit x2
|
0.00%
0/20 • Adverse events were collected after informed consent was obtained until the follow-up telephone call 24 hours following hospital discharge.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected after informed consent was obtained until the follow-up telephone call 24 hours following hospital discharge.
|
|
Gastrointestinal disorders
vomit x3
|
0.00%
0/20 • Adverse events were collected after informed consent was obtained until the follow-up telephone call 24 hours following hospital discharge.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected after informed consent was obtained until the follow-up telephone call 24 hours following hospital discharge.
|
|
Nervous system disorders
PACU delirium
|
0.00%
0/20 • Adverse events were collected after informed consent was obtained until the follow-up telephone call 24 hours following hospital discharge.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected after informed consent was obtained until the follow-up telephone call 24 hours following hospital discharge.
|
|
Respiratory, thoracic and mediastinal disorders
poss. airway swelling
|
0.00%
0/20 • Adverse events were collected after informed consent was obtained until the follow-up telephone call 24 hours following hospital discharge.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected after informed consent was obtained until the follow-up telephone call 24 hours following hospital discharge.
|
|
Respiratory, thoracic and mediastinal disorders
coughing
|
5.0%
1/20 • Number of events 1 • Adverse events were collected after informed consent was obtained until the follow-up telephone call 24 hours following hospital discharge.
|
0.00%
0/19 • Adverse events were collected after informed consent was obtained until the follow-up telephone call 24 hours following hospital discharge.
|
|
Nervous system disorders
headache
|
5.0%
1/20 • Number of events 1 • Adverse events were collected after informed consent was obtained until the follow-up telephone call 24 hours following hospital discharge.
|
0.00%
0/19 • Adverse events were collected after informed consent was obtained until the follow-up telephone call 24 hours following hospital discharge.
|
|
Respiratory, thoracic and mediastinal disorders
stridor
|
5.0%
1/20 • Number of events 1 • Adverse events were collected after informed consent was obtained until the follow-up telephone call 24 hours following hospital discharge.
|
0.00%
0/19 • Adverse events were collected after informed consent was obtained until the follow-up telephone call 24 hours following hospital discharge.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place