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Analgesic Effect of IV Acetaminophen in Tonsillectomies

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Arlyne Thung, Nationwide Children's Hospital
ClinicalTrials.gov Identifier:
NCT01691690
First received: May 30, 2012
Last updated: February 21, 2017
Last verified: February 2017
Results First Received: September 7, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions: Adenotonsillitis
Tonsillitis
Interventions: Drug: Acetaminophen (paracetamol)
Drug: Normal Saline Flush
Drug: Midazolam
Drug: Sevoflurane
Drug: Nitrous Oxide/Oxygen
Drug: Propofol
Drug: Morphine
Drug: Ondansetron
Drug: Dexamethasone

  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
No text entered.

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
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.


Participant Flow:   Overall Study
    IV Acetaminophen   Saline Placebo
STARTED   125   125 
COMPLETED   118   121 
NOT COMPLETED   7   4 



  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.
No text entered.

Reporting Groups
  Description
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.

Total Total of all reporting groups

Baseline Measures
   IV Acetaminophen   Saline Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 118   121   239 
Age 
[Units: Years]
Mean (Standard Deviation)
 4.87  (1.53)   4.84  (1.42)   4.855  (1.476) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      62  52.5%      59  48.8%      121  50.6% 
Male      56  47.5%      62  51.2%      118  49.4% 
Height (cm) 
[Units: Centimeters]
Mean (Standard Deviation)
 109.31  (10.82)   108.78  (10.37)   109.04  (10.58) 
Weight (kg) 
[Units: Kilograms]
Mean (Standard Deviation)
 18.85  (4.74)   18.27  (4.02)   18.56  (4.39) 
Body Mass Index (kg/m2) 
[Units: Kg/m2]
Mean (Standard Deviation)
 15.56  (1.58)   15.29  (1.36)   15.42  (1.47) 
Procedure time (min) 
[Units: Minutes]
Mean (Standard Deviation)
 15.85  (5.78)   16.65  (5.90)   16.26  (5.85) 
Extubation time (min) 
[Units: Minutes]
Mean (Standard Deviation)
 16.65  (7.68)   15.38  (8.52)   16.01  (8.12) 
Post-Anesthetic Care Unit time (min) 
[Units: Minutes]
Mean (Standard Deviation)
 64.57  (23.41)   65.07  (19.40)   64.82  (21.44) 
Time to first analgesic on unit (min) 
[Units: Minutes]
Mean (Standard Deviation)
 298.36  (97.52)   297.09  (106.91)   297.74  (101.97) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   FLACC Pain Score Greater Than or Equal to 4   [ Time Frame: 0-60 mins post-operatively ]

2.  Secondary:   Analgesics Administered After Arrival to Inpatient Ward and Number of Participants Requiring Each   [ Time Frame: 8-12 hours post-operatively ]

3.  Secondary:   Time of First Opioid Analgesia in PACU   [ Time Frame: 0-90 minutes post-operatively ]


  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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Arlyne Thung
Organization: Nationwide Children's Hospital
phone: (614) 722-4200
e-mail: Arlyne.Thung@NationwideChildrens.org


Publications:

Responsible Party: Arlyne Thung, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT01691690     History of Changes
Other Study ID Numbers: IRB12-00097
Study First Received: May 30, 2012
Results First Received: September 7, 2016
Last Updated: February 21, 2017