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Trial record 70 of 1890 for:    Acetaminophen

Acetaminophen's Efficacy For Post-operative Pain

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ClinicalTrials.gov Identifier: NCT01721486
Recruitment Status : Completed
First Posted : November 5, 2012
Results First Posted : June 8, 2017
Last Update Posted : June 8, 2017
Sponsor:
Information provided by (Responsible Party):
Kaveh Aslani, MD, William Beaumont Hospitals

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Care Provider);   Primary Purpose: Treatment
Conditions Tonsillitis
Airway Obstruction
Difficulty Swallowing
Interventions Drug: IV acetaminophen
Drug: PO acetaminophen
Enrollment 41
Recruitment Details Participants were enrolled over a period of 23 months in the pre-operative setting of an out-patient surgical unit.
Pre-assignment Details  
Arm/Group Title Study Group Control Group
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 21 20
Completed 20 19
Not Completed 1 1
Reason Not Completed
Protocol Violation             1             0
Physician Decision             0             1
Arm/Group Title Study Group Control Group Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 20 19 39
Hide Baseline Analysis Population Description
Baseline participant number does not include 2 patients removed from study.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 19 participants 39 participants
<=18 years
20
 100.0%
19
 100.0%
39
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 19 participants 39 participants
Female
11
  55.0%
10
  52.6%
21
  53.8%
Male
9
  45.0%
9
  47.4%
18
  46.2%
1.Primary Outcome
Title Total Pain Medication
Hide Description All pain medication documented during the first 24 hours postoperatively, in mg morphine equivalents.
Time Frame From time of PACU admission until 24 hours post-operatively.
Hide Outcome Measure Data
Hide Analysis Population Description
Only patients receiving rescue pain medication were analyzed.
Arm/Group Title Study Group Control Group
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 14 14
Median (Inter-Quartile Range)
Unit of Measure: mg
1.7
(0 to 5.5)
2.2
(0 to 4.5)
2.Secondary Outcome
Title FLACC: Face, Legs, Activity, Cry & Consolability (FLACC) Pain Assessment Scores
Hide Description 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.
Time Frame At time of admission into PACU.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Study Group Control Group
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 20 19
Median (Full Range)
Unit of Measure: units on a scale
0
(0 to 10)
0
(0 to 8)
3.Secondary Outcome
Title Incidence of Post-operative Vomiting
Hide Description Percentage of subjects with at least one episode of post-operative vomiting
Time Frame From admission into PACU until 24 hours post-hospital discharge. At the conclusion of enrollment, this measure will be assessed for all participants.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Study Group Control Group
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 20 19
Measure Type: Count of Participants
Unit of Measure: Participants
1
   5.0%
3
  15.8%
4.Secondary Outcome
Title Parental Satisfaction With Pain Control.
Hide Description 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.
Time Frame 24 hours post hospital discharge.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Study Group Control Group
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 20 19
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
9
(8 to 10)
8
(8 to 10)
Time Frame Adverse events were collected after informed consent was obtained until the follow-up telephone call 24 hours following hospital discharge.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Study Group Control Group
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Study Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)      0/19 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Study Group Control Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/20 (0.00%)      1/19 (5.26%)    
Blood and lymphatic system disorders     
bleeding *  0/20 (0.00%)  1/19 (5.26%) 
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Study Group Control Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/20 (20.00%)      6/19 (31.58%)    
Gastrointestinal disorders     
vomit x1 *  1/20 (5.00%)  1 1/19 (5.26%)  1
vomit x2 *  0/20 (0.00%)  0 1/19 (5.26%)  1
vomit x3 *  0/20 (0.00%)  0 1/19 (5.26%)  1
Nervous system disorders     
nausea *  0/20 (0.00%)  0 1/19 (5.26%)  1
PACU delirium *  0/20 (0.00%)  0 1/19 (5.26%)  1
headache *  1/20 (5.00%)  1 0/19 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
poss. airway swelling *  0/20 (0.00%)  0 1/19 (5.26%)  1
coughing *  1/20 (5.00%)  1 0/19 (0.00%)  0
stridor *  1/20 (5.00%)  1 0/19 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
The number of participants in both groups are very small. Data in pain scores outcome was skewed.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Kaveh Aslani, MD
Organization: Beaumont Hsopital
Phone: 248-898-1907
EMail: kaveh.aslani@beaumont.org
Layout table for additonal information
Responsible Party: Kaveh Aslani, MD, William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT01721486     History of Changes
Other Study ID Numbers: 2012-162
First Submitted: September 27, 2012
First Posted: November 5, 2012
Results First Submitted: January 18, 2017
Results First Posted: June 8, 2017
Last Update Posted: June 8, 2017