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Trial record 2 of 74 for:    Codeine AND Acetaminophen

A Comparison of Postoperative Tramadol Versus Acetaminophen With Codeine in Children Undergoing Tonsillectomy

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ClinicalTrials.gov Identifier: NCT01267136
Recruitment Status : Completed
First Posted : December 28, 2010
Results First Posted : April 17, 2014
Last Update Posted : April 17, 2014
Sponsor:
Information provided by (Responsible Party):
Children's Hospitals and Clinics of Minnesota

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Tonsillitis
Pain
Interventions Drug: Codeine with acetaminophen
Drug: Tramadol suspension
Enrollment 84
Recruitment Details The study was introduced to 137 potential subjects during or following an outpatient office evaluation with an ear/nose/throat (ENT) surgeon between February 2011 and May 2012.
Pre-assignment Details The study was introduced to 137 potential subjects, and 84 children were enrolled in the study and assigned to one of the two study arms.
Arm/Group Title Capital® With Codeine Suspension Tramadol Suspension
Hide Arm/Group Description Codeine with acetaminophen : Liquid codeine/acetaminophen (Capital® 5mL= 120mg acetaminophen/12 mg codeine) 0.72 mg/kg [=0.3 mL/kg] (max. 36 mg) PO Q6h, plus 0.72 mg/kg (max. 36 mg) PO Q3h pro re nata (PRN) (max. of 3 PRN doses/day) Tramadol suspension : Liquid tramadol 1.05 mg/kg [=0.3 mL/kg] (max. 52.5 mg) PO Q6h, plus 1.05 mg/kg (max. 52.5 mg) PO Q3h pro re nata (PRN) (max. of 3 PRN doses/day).
Period Title: Overall Study
Started 42 42
Completed 38 36
Not Completed 4 6
Arm/Group Title Capital® With Codeine Suspension Tramadol Suspension Total
Hide Arm/Group Description Codeine with acetaminophen : Liquid codeine/acetaminophen (Capital® 5mL= 120mg acetaminophen/12 mg codeine) 0.72 mg/kg [=0.3 mL/kg] (max. 36 mg) PO Q6h, plus 0.72 mg/kg (max. 36 mg) PO Q3h PRN (max. of 3 PRN doses/day) Tramadol suspension : Liquid tramadol 1.05 mg/kg [=0.3 mL/kg] (max. 52.5 mg) PO Q6h, plus 1.05 mg/kg (max. 52.5 mg) PO Q3h PRN (max. of 3 PRN doses/day). Total of all reporting groups
Overall Number of Baseline Participants 42 42 84
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 42 participants 84 participants
<=18 years
42
 100.0%
42
 100.0%
84
 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%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 42 participants 42 participants 84 participants
6.4  (2.3) 6.6  (2.3) 6.5  (2.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 42 participants 84 participants
Female
26
  61.9%
25
  59.5%
51
  60.7%
Male
16
  38.1%
17
  40.5%
33
  39.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 42 participants 42 participants 84 participants
42 42 84
1.Primary Outcome
Title Efficacy of Two Different Liquid Pain Medications: Tramadol vs. Codeine/Acetaminophen During the Post-tonsillectomy Recovery Period.
Hide Description Average number of post-operative days with pain score >4/10. Pain score assessments were administered once daily by parents using either the Numeric Rating Scale (NRS-11) (with anchors 0=no pain and 10=highest pain imaginable) for children ages 8-15 (von Baeyer et al., 2009) or the Faces Pain Scale-Revised (FPS-R) (with anchors 0=no pain and 10=highest pain imaginable) for children ages 4-10 (Hicks et al., 2001).
Time Frame Efficacy was assessed daily during the 10-day postoperative recovery period.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Capital® With Codeine Suspension Tramadol Suspension
Hide Arm/Group Description:
Codeine with acetaminophen : Liquid codeine/acetaminophen (Capital® 5mL= 120mg acetaminophen/12 mg codeine) 0.72 mg/kg [=0.3 mL/kg] (max. 36 mg) PO Q6h, plus 0.72 mg/kg (max. 36 mg) PO Q3h PRN (max. of 3 PRN doses/day)
Tramadol suspension : Liquid tramadol 1.05 mg/kg [=0.3 mL/kg] (max. 52.5 mg) PO Q6h, plus 1.05 mg/kg (max. 52.5 mg) PO Q3h PRN (max. of 3 PRN doses/day).
Overall Number of Participants Analyzed 38 36
Median (Full Range)
Unit of Measure: days
1.5
(0 to 9)
1
(0 to 9)
2.Secondary Outcome
Title Number of Participants Reporting Side Effects During the Post-tonsillectomy Recovery Period.
Hide Description Parent-reported side effects entered in 10-day diary.
Time Frame Side effects will be observed and recorded daily by caregivers for a total of 10 days in the take-home diary.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Capital® With Codeine Suspension Tramadol Suspension
Hide Arm/Group Description:
Codeine with acetaminophen: Liquid codeine/acetaminophen (Capital® 5mL= 120mg acetaminophen/12 mg codeine) 0.72 mg/kg [=0.3 mL/kg] (max. 36 mg) PO Q6h, plus 0.72 mg/kg (max. 36 mg) PO Q3h PRN (max. of 3 PRN doses/day)
Tramadol suspension: Liquid tramadol 1.05 mg/kg [=0.3 mL/kg] (max. 52.5 mg) PO Q6h, plus 1.05 mg/kg (max. 52.5 mg) PO Q3h PRN (max. of 3 PRN doses/day).
Overall Number of Participants Analyzed 38 36
Measure Type: Number
Unit of Measure: participants
Nausea 20 20
Vomiting 21 18
Fever 11 10
Itching 5 12
Rash 1 1
Sweating 9 7
Dizziness 15 17
Headache 12 17
Constipation 21 21
Oversedation 14 8
Tonsil bleed 3 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Capital® With Codeine Suspension Tramadol Suspension
Hide Arm/Group Description Codeine with acetaminophen : Liquid codeine/acetaminophen (Capital® 5mL= 120mg acetaminophen/12 mg codeine) 0.72 mg/kg [=0.3 mL/kg] (max. 36 mg) PO Q6h, plus 0.72 mg/kg (max. 36 mg) PO Q3h PRN (max. of 3 PRN doses/day) Tramadol suspension : Liquid tramadol 1.05 mg/kg [=0.3 mL/kg] (max. 52.5 mg) PO Q6h, plus 1.05 mg/kg (max. 52.5 mg) PO Q3h PRN (max. of 3 PRN doses/day).
All-Cause Mortality
Capital® With Codeine Suspension Tramadol Suspension
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Capital® With Codeine Suspension Tramadol Suspension
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/42 (2.38%)      1/42 (2.38%)    
Blood and lymphatic system disorders     
Tonsil bleed requiring hospitalization * [1]  1/42 (2.38%)  1 0/42 (0.00%)  0
Gastrointestinal disorders     
Difficulty with oral intake * [2]  0/42 (0.00%)  0 1/42 (2.38%)  1
General disorders     
Throat pain requiring hospitalization * [3]  0/42 (0.00%)  0 1/42 (2.38%)  1
Dehydration * [2]  0/42 (0.00%)  0 1/42 (2.38%)  1
*
Indicates events were collected by non-systematic assessment
[1]
Patient had hypoplastic left heart syndrome and was pacemaker-dependent. This child experienced a life-threatening tonsil hemorrhage one week after surgery, requiring resuscitation and hospitalization, and discontinuation of the study medication.
[2]
Patient was hospitalized for difficulty with oral intake, dehydration, and throat pain. This patients was rehydrated and switched to acetaminophen and hydrocodone (Lortab) for pain management following discharge.
[3]
Patient was hospitalized for difficulty with oral intake, dehydration, and throat pain. This patient was rehydrated and switched to acetaminophen and hydrocodone (Lortab) for pain management following discharge.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Capital® With Codeine Suspension Tramadol Suspension
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   33/38 (86.84%)      35/36 (97.22%)    
Blood and lymphatic system disorders     
Tonsil bleed   2/38 (5.26%)  0/36 (0.00%) 
Gastrointestinal disorders     
Vomiting   21/38 (55.26%)  18/36 (50.00%) 
Constipation   21/38 (55.26%)  21/36 (58.33%) 
General disorders     
Sweating   9/38 (23.68%)  7/36 (19.44%) 
Oversedation   14/38 (36.84%)  8/36 (22.22%) 
Infections and infestations     
Fever   11/38 (28.95%)  10/36 (27.78%) 
Nervous system disorders     
Nausea   20/38 (52.63%)  20/36 (55.56%) 
Dizziness   15/38 (39.47%)  17/36 (47.22%) 
Headache   12/38 (31.58%)  17/36 (47.22%) 
Skin and subcutaneous tissue disorders     
Itching   5/38 (13.16%)  12/36 (33.33%) 
Rash   1/38 (2.63%)  1/36 (2.78%) 
Indicates events were collected by systematic assessment
There was insufficient power to detect differences in safety.
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: Andrea Postier/Clinical Research Program Manager
Organization: Children's Hospitals and Clinics of Minnesota
Phone: 612-813-6409
EMail: andrea.postier@childrensmn.org
Publications:
Bamigbade TA, Langford, RM. The clinical use of tramadol hydrochloride Pain Rev 1998;5 155-82.
Dorn MT FN, Quinn FB. Tonsillitis, Tonsillectomy, and Adenoidectomy. Grand Rounds, UTMB - Department of Otolaryngology. December 1999.
Drake A CM. Tonsillectomy. EMedicine2003. Available at: http://www.emedicine.com/ent/topic315.htm.
Fortier MM, J; Martin, S; Kain, Z. Children's pain at home following ambulatory surgery. J Pain2009;10(4 (Suppl1)):106.
Oxford Pain Site. Available at: http://www.medicine.oc.ac.uk/bandolier/booth/painpag/acute.html
Layout table for additonal information
Responsible Party: Children's Hospitals and Clinics of Minnesota
ClinicalTrials.gov Identifier: NCT01267136     History of Changes
Other Study ID Numbers: 1010-086
First Submitted: December 23, 2010
First Posted: December 28, 2010
Results First Submitted: December 19, 2013
Results First Posted: April 17, 2014
Last Update Posted: April 17, 2014