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Acetaminophen's Efficacy For Post-operative Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kaveh Aslani, MD, William Beaumont Hospitals
ClinicalTrials.gov Identifier:
NCT01721486
First received: September 27, 2012
Last updated: June 6, 2017
Last verified: June 2017
Results First Received: January 18, 2017  
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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were enrolled over a period of 23 months in the pre-operative setting of an out-patient surgical unit.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.


Participant Flow:   Overall Study
    Study Group   Control Group
STARTED   21   20 
COMPLETED   20   19 
NOT COMPLETED   1   1 
Protocol Violation                1                0 
Physician Decision                0                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Baseline participant number does not include 2 patients removed from study.

Reporting Groups
  Description
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.

Total Total of all reporting groups

Baseline Measures
   Study Group   Control Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 20   19   39 
Age 
[Units: Participants]
Count of 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 
[Units: Participants]
Count of Participants
     
Female      11  55.0%      10  52.6%      21  53.8% 
Male      9  45.0%      9  47.4%      18  46.2% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Total Pain Medication   [ Time Frame: From time of PACU admission until 24 hours post-operatively. ]

2.  Secondary:   FLACC: Face, Legs, Activity, Cry & Consolability (FLACC) Pain Assessment Scores   [ Time Frame: At time of admission into PACU. ]

3.  Secondary:   Incidence 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. ]

4.  Secondary:   Parental Satisfaction With Pain Control.   [ Time Frame: 24 hours post hospital discharge. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The number of participants in both groups are very small. Data in pain scores outcome was skewed.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Kaveh Aslani, MD
Organization: Beaumont Hsopital
phone: 248-898-1907
e-mail: kaveh.aslani@beaumont.org



Responsible Party: Kaveh Aslani, MD, William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT01721486     History of Changes
Other Study ID Numbers: 2012-162
Study First Received: September 27, 2012
Results First Received: January 18, 2017
Last Updated: June 6, 2017