Trial Outcomes & Findings for Analgesic Effect of IV Acetaminophen in Tonsillectomies (NCT NCT01691690)
NCT ID: NCT01691690
Last Updated: 2017-04-06
Results Overview
The Face, Legs, Activity, Cry, Consolability scale or FLACC scale is a measurement used to assess pain for children between the ages of 2 months and 7 years or individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. 5 pain measurements were performed at 0, 5, 15, 30, and 60 minutes after PACU arrival. This is the number of participants who reached a FLACC score \>/= 4 at one or more time points.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
250 participants
Primary outcome timeframe
0-60 mins post-operatively
Results posted on
2017-04-06
Participant Flow
Participant milestones
| Measure |
IV Acetaminophen
Patients will receive pre-medication with oral midazolam. Participants of this experimental arm of the study will receive Acetaminophen IV to evaluate opioid-sparing effect and pain score reduction.
Acetaminophen (paracetamol): Acetaminophen IV (15 mg/kg) will be infused intraoperatively over 15 minutes to evaluate the opioid-sparing effect and pain score reduction in pediatric patients undergoing tonsillectomy or adenotonsillectomy procedures.
Morphine (hydromorphone): Morphine (0.1 mg/kg) will be added to manage pain prior to intubation.
|
Saline Placebo
Patients will receive pre-medication with oral midazolam. Participants of this control arm will receive saline to establish a control model for evaluating opioid-sparing effect and pain score reduction compared to the intervention arm.
Sodium Chloride (saline): 0.9% Sodium Chloride Placebo will be infused intraoperatively over 15 minutes to establish a control model while evaluating the pain score differences in pediatric patients undergoing tonsillectomy or adenotonsillectomy procedures.
Morphine (hydromorphone): Morphine (0.1 mg/kg) will be added to manage pain prior to intubation.
|
|---|---|---|
|
Overall Study
STARTED
|
125
|
125
|
|
Overall Study
COMPLETED
|
118
|
121
|
|
Overall Study
NOT COMPLETED
|
7
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Analgesic Effect of IV Acetaminophen in Tonsillectomies
Baseline characteristics by cohort
| Measure |
IV Acetaminophen
n=118 Participants
Patients will receive pre-medication with oral midazolam. Participants of this experimental arm of the study will receive Acetaminophen IV to evaluate opioid-sparing effect and pain score reduction.
Acetaminophen (paracetamol): Acetaminophen IV (15 mg/kg) will be infused intraoperatively over 15 minutes to evaluate the opioid-sparing effect and pain score reduction in pediatric patients undergoing tonsillectomy or adenotonsillectomy procedures.
Morphine (hydromorphone): Morphine (0.1 mg/kg) will be added to manage pain prior to intubation.
|
Saline Placebo
n=121 Participants
Patients will receive pre-medication with oral midazolam. Participants of this control arm will receive saline to establish a control model for evaluating opioid-sparing effect and pain score reduction compared to the intervention arm.
Sodium Chloride (saline): 0.9% Sodium Chloride Placebo will be infused intraoperatively over 15 minutes to establish a control model while evaluating the pain score differences in pediatric patients undergoing tonsillectomy or adenotonsillectomy procedures.
Morphine (hydromorphone): Morphine (0.1 mg/kg) will be added to manage pain prior to intubation.
|
Total
n=239 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
4.87 years
STANDARD_DEVIATION 1.53 • n=5 Participants
|
4.84 years
STANDARD_DEVIATION 1.42 • n=7 Participants
|
4.855 years
STANDARD_DEVIATION 1.476 • n=5 Participants
|
|
Sex: Female, Male
Female
|
62 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
121 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
56 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
118 Participants
n=5 Participants
|
|
Height (cm)
|
109.31 centimeters
STANDARD_DEVIATION 10.82 • n=5 Participants
|
108.78 centimeters
STANDARD_DEVIATION 10.37 • n=7 Participants
|
109.04 centimeters
STANDARD_DEVIATION 10.58 • n=5 Participants
|
|
Weight (kg)
|
18.85 kilograms
STANDARD_DEVIATION 4.74 • n=5 Participants
|
18.27 kilograms
STANDARD_DEVIATION 4.02 • n=7 Participants
|
18.56 kilograms
STANDARD_DEVIATION 4.39 • n=5 Participants
|
|
Body Mass Index (kg/m2)
|
15.56 Kg/m2
STANDARD_DEVIATION 1.58 • n=5 Participants
|
15.29 Kg/m2
STANDARD_DEVIATION 1.36 • n=7 Participants
|
15.42 Kg/m2
STANDARD_DEVIATION 1.47 • n=5 Participants
|
|
Procedure time (min)
|
15.85 minutes
STANDARD_DEVIATION 5.78 • n=5 Participants
|
16.65 minutes
STANDARD_DEVIATION 5.90 • n=7 Participants
|
16.26 minutes
STANDARD_DEVIATION 5.85 • n=5 Participants
|
|
Extubation time (min)
|
16.65 minutes
STANDARD_DEVIATION 7.68 • n=5 Participants
|
15.38 minutes
STANDARD_DEVIATION 8.52 • n=7 Participants
|
16.01 minutes
STANDARD_DEVIATION 8.12 • n=5 Participants
|
|
Post-Anesthetic Care Unit time (min)
|
64.57 minutes
STANDARD_DEVIATION 23.41 • n=5 Participants
|
65.07 minutes
STANDARD_DEVIATION 19.40 • n=7 Participants
|
64.82 minutes
STANDARD_DEVIATION 21.44 • n=5 Participants
|
|
Time to first analgesic on unit (min)
|
298.36 minutes
STANDARD_DEVIATION 97.52 • n=5 Participants
|
297.09 minutes
STANDARD_DEVIATION 106.91 • n=7 Participants
|
297.74 minutes
STANDARD_DEVIATION 101.97 • n=5 Participants
|
PRIMARY outcome
Timeframe: 0-60 mins post-operativelyThe Face, Legs, Activity, Cry, Consolability scale or FLACC scale is a measurement used to assess pain for children between the ages of 2 months and 7 years or individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. 5 pain measurements were performed at 0, 5, 15, 30, and 60 minutes after PACU arrival. This is the number of participants who reached a FLACC score \>/= 4 at one or more time points.
Outcome measures
| Measure |
IV Acetaminophen
n=118 Participants
Patients will receive pre-medication with oral midazolam. Participants of this experimental arm of the study will receive Acetaminophen IV to evaluate opioid-sparing effect and pain score reduction.
Acetaminophen (paracetamol): Acetaminophen IV (15 mg/kg) will be infused intraoperatively over 15 minutes to evaluate the opioid-sparing effect and pain score reduction in pediatric patients undergoing tonsillectomy or adenotonsillectomy procedures.
Morphine (hydromorphone): Morphine (0.1 mg/kg) will be added to manage pain prior to intubation.
|
Saline Placebo
n=121 Participants
Patients will receive pre-medication with oral midazolam. Participants of this control arm will receive saline to establish a control model for evaluating opioid-sparing effect and pain score reduction compared to the intervention arm.
Sodium Chloride (saline): 0.9% Sodium Chloride Placebo will be infused intraoperatively over 15 minutes to establish a control model while evaluating the pain score differences in pediatric patients undergoing tonsillectomy or adenotonsillectomy procedures.
Morphine (hydromorphone): Morphine (0.1 mg/kg) will be added to manage pain prior to intubation.
|
|---|---|---|
|
FLACC Pain Score Greater Than or Equal to 4
|
58 Participants
|
69 Participants
|
SECONDARY outcome
Timeframe: 8-12 hours post-operativelyPopulation: Comparing both groups for the time study subjects required breakthrough pain medication on the ward.
Analgesics administered after arrival to the inpatient ward included hydrocodone/acetaminophen, oxycodone, NSAIDS, acetaminophen, and morphine.
Outcome measures
| Measure |
IV Acetaminophen
n=118 Participants
Patients will receive pre-medication with oral midazolam. Participants of this experimental arm of the study will receive Acetaminophen IV to evaluate opioid-sparing effect and pain score reduction.
Acetaminophen (paracetamol): Acetaminophen IV (15 mg/kg) will be infused intraoperatively over 15 minutes to evaluate the opioid-sparing effect and pain score reduction in pediatric patients undergoing tonsillectomy or adenotonsillectomy procedures.
Morphine (hydromorphone): Morphine (0.1 mg/kg) will be added to manage pain prior to intubation.
|
Saline Placebo
n=120 Participants
Patients will receive pre-medication with oral midazolam. Participants of this control arm will receive saline to establish a control model for evaluating opioid-sparing effect and pain score reduction compared to the intervention arm.
Sodium Chloride (saline): 0.9% Sodium Chloride Placebo will be infused intraoperatively over 15 minutes to establish a control model while evaluating the pain score differences in pediatric patients undergoing tonsillectomy or adenotonsillectomy procedures.
Morphine (hydromorphone): Morphine (0.1 mg/kg) will be added to manage pain prior to intubation.
|
|---|---|---|
|
Analgesics Administered After Arrival to Inpatient Ward and Number of Participants Requiring Each
morphine
|
1 Participants
|
0 Participants
|
|
Analgesics Administered After Arrival to Inpatient Ward and Number of Participants Requiring Each
hydrocodone/acetaminophen
|
68 Participants
|
57 Participants
|
|
Analgesics Administered After Arrival to Inpatient Ward and Number of Participants Requiring Each
oxycodone
|
31 Participants
|
39 Participants
|
|
Analgesics Administered After Arrival to Inpatient Ward and Number of Participants Requiring Each
NSAIDS
|
15 Participants
|
22 Participants
|
|
Analgesics Administered After Arrival to Inpatient Ward and Number of Participants Requiring Each
acetaminophen
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 0-90 minutes post-operativelyMean time to first drug administration among patients requiring opioid analgesia in the PACU.
Outcome measures
| Measure |
IV Acetaminophen
n=118 Participants
Patients will receive pre-medication with oral midazolam. Participants of this experimental arm of the study will receive Acetaminophen IV to evaluate opioid-sparing effect and pain score reduction.
Acetaminophen (paracetamol): Acetaminophen IV (15 mg/kg) will be infused intraoperatively over 15 minutes to evaluate the opioid-sparing effect and pain score reduction in pediatric patients undergoing tonsillectomy or adenotonsillectomy procedures.
Morphine (hydromorphone): Morphine (0.1 mg/kg) will be added to manage pain prior to intubation.
|
Saline Placebo
n=121 Participants
Patients will receive pre-medication with oral midazolam. Participants of this control arm will receive saline to establish a control model for evaluating opioid-sparing effect and pain score reduction compared to the intervention arm.
Sodium Chloride (saline): 0.9% Sodium Chloride Placebo will be infused intraoperatively over 15 minutes to establish a control model while evaluating the pain score differences in pediatric patients undergoing tonsillectomy or adenotonsillectomy procedures.
Morphine (hydromorphone): Morphine (0.1 mg/kg) will be added to manage pain prior to intubation.
|
|---|---|---|
|
Time of First Opioid Analgesia in PACU
|
56.80 minutes
Standard Deviation 14.15
|
60.46 minutes
Standard Deviation 20.51
|
Adverse Events
IV Acetaminophen
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Saline Placebo
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
IV Acetaminophen
n=118 participants at risk
Patients will receive pre-medication with oral midazolam. Participants of this experimental arm of the study will receive Acetaminophen IV to evaluate opioid-sparing effect and pain score reduction.
Acetaminophen (paracetamol): Acetaminophen IV (15 mg/kg) will be infused intraoperatively over 15 minutes to evaluate the opioid-sparing effect and pain score reduction in pediatric patients undergoing tonsillectomy or adenotonsillectomy procedures.
Morphine (hydromorphone): Morphine (0.1 mg/kg) will be added to manage pain prior to intubation.
|
Saline Placebo
n=121 participants at risk
Patients will receive pre-medication with oral midazolam. Participants of this control arm will receive saline to establish a control model for evaluating opioid-sparing effect and pain score reduction compared to the intervention arm.
Sodium Chloride (saline): 0.9% Sodium Chloride Placebo will be infused intraoperatively over 15 minutes to establish a control model while evaluating the pain score differences in pediatric patients undergoing tonsillectomy or adenotonsillectomy procedures.
Morphine (hydromorphone): Morphine (0.1 mg/kg) will be added to manage pain prior to intubation.
|
|---|---|---|
|
General disorders
Post-operative nausea or vomiting (PONV)
|
0.85%
1/118 • Adverse event data were collected for each patient from pre-operative registration, peri-operatively, until hospital discharge post-operatively (Data collection occurred over the course of a 24 hour period).
|
3.3%
4/121 • Adverse event data were collected for each patient from pre-operative registration, peri-operatively, until hospital discharge post-operatively (Data collection occurred over the course of a 24 hour period).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory complications
|
8.5%
10/118 • Adverse event data were collected for each patient from pre-operative registration, peri-operatively, until hospital discharge post-operatively (Data collection occurred over the course of a 24 hour period).
|
9.9%
12/121 • Adverse event data were collected for each patient from pre-operative registration, peri-operatively, until hospital discharge post-operatively (Data collection occurred over the course of a 24 hour period).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place