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Tonsillectomy is the most common pediatric surgical procedure performed in the US. The postoperative period can be particularly painful. Codeine (usually in mixed formulation with acetaminophen) is the most commonly prescribed opioid in the US. However, evolving data questions its ability to provide optimal pain relief, while avoiding side effects, especially in the postoperative setting. Tramadol may be a better option for children in the postoperative setting due to its well-documented analgesic properties, low potential for side effects, and excellent safety profile. Seventy-two children scheduled to undergo tonsillectomy (with or without adenoidectomy) at Children's will be invited to participate in a randomized, prospective, double-blinded study to evaluate the efficacy and side effects of codeine with acetaminophen versus tramadol. Using a 10-day take-home diary, caregivers will be asked to record daily information about their child's postoperative pain and other core outcomes and domains as recommended in the recent consensus statement put forth by the Pediatric Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) (McGrath et al., 2008). This study will offer new information regarding the efficacy and side effects associated with tramadol as compared with codeine/acetaminophen (the current practice standard) in a pediatric population.
Hypotheses
H1: Children who receive scheduled tramadol following tonsillectomy will report better pain control than children who receive scheduled codeine/acetaminophen.
H2: Children who receive scheduled tramadol following tonsillectomy will report fewer side effects than children who receive scheduled codeine/acetaminophen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Capital® with Codeine Suspension | Experimental |
| |
| Tramadol suspension | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Codeine with acetaminophen | Drug | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of Two Different Liquid Pain Medications: Tramadol vs. Codeine/Acetaminophen During the Post-tonsillectomy Recovery Period. | 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). | Efficacy was assessed daily during the 10-day postoperative recovery period. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reporting Side Effects During the Post-tonsillectomy Recovery Period. | Parent-reported side effects entered in 10-day diary. | Side effects will be observed and recorded daily by caregivers for a total of 10 days in the take-home diary. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stefan J Friedrichsdorf, M.D. | Children's Hospitals and Clinics of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospitals and Clinics of Minnesota | Minneapolis | Minnesota | 55404 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17940786 | Background | Atef A, Fawaz AA. Peritonsillar infiltration with tramadol improves pediatric tonsillectomy pain. Eur Arch Otorhinolaryngol. 2008 May;265(5):571-4. doi: 10.1007/s00405-007-0479-6. Epub 2007 Oct 17. | |
| 9722388 | Background | Bamigbade TA, Langford RM. Tramadol hydrochloride: an overview of current use. Hosp Med. 1998 May;59(5):373-6. |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Capital® With Codeine Suspension | 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) |
| FG001 | Tramadol Suspension | 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Capital® With Codeine Suspension | 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) |
| BG001 | Tramadol Suspension |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Efficacy of Two Different Liquid Pain Medications: Tramadol vs. Codeine/Acetaminophen During the Post-tonsillectomy Recovery Period. | 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). | Posted | Median | Full Range | days | Efficacy was assessed daily during the 10-day postoperative recovery period. |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Capital® With Codeine Suspension | 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) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tonsil bleed requiring hospitalization | Blood and lymphatic system disorders | Non-systematic Assessment | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Nervous system disorders | Systematic Assessment |
There was insufficient power to detect differences in safety.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrea Postier/Clinical Research Program Manager | Children's Hospitals and Clinics of Minnesota | 612-813-6409 | andrea.postier@childrensmn.org |
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| ID | Term |
|---|---|
| D014069 | Tonsillitis |
| D010146 | Pain |
| ID | Term |
|---|---|
| D010612 | Pharyngitis |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010608 | Pharyngeal Diseases |
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| ID | Term |
|---|---|
| D003061 | Codeine |
| D000082 | Acetaminophen |
| D004467 | Economics |
| D014147 | Tramadol |
| ID | Term |
|---|---|
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
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|
| Tramadol suspension | Drug | 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). |
|
|
| 14527704 | Background | Chambers CT, Finley AG, McGrath PJ, Walsh TM. The parents' postoperative pain measure: replication and extension to 2-6-year-old children. Pain. 2003 Oct;105(3):437-443. doi: 10.1016/S0304-3959(03)00256-2. |
| 9121819 | Background | Chambers CT, Reid GJ, McGrath PJ, Finley GA. Development and preliminary validation of a postoperative pain measure for parents. Pain. 1996 Dec;68(2-3):307-13. doi: 10.1016/s0304-3959(96)03209-5. |
| 16717306 | Background | Chu YC, Lin SM, Hsieh YC, Chan KH, Tsou MY. Intraoperative administration of tramadol for postoperative nurse-controlled analgesia resulted in earlier awakening and less sedation than morphine in children after cardiac surgery. Anesth Analg. 2006 Jun;102(6):1668-73. doi: 10.1213/01.ANE.0000219587.02263.A0. |
| 19692698 | Background | Ciszkowski C, Madadi P, Phillips MS, Lauwers AE, Koren G. Codeine, ultrarapid-metabolism genotype, and postoperative death. N Engl J Med. 2009 Aug 20;361(8):827-8. doi: 10.1056/NEJMc0904266. No abstract available. |
| 17332198 | Background | Clark E, Plint AC, Correll R, Gaboury I, Passi B. A randomized, controlled trial of acetaminophen, ibuprofen, and codeine for acute pain relief in children with musculoskeletal trauma. Pediatrics. 2007 Mar;119(3):460-7. doi: 10.1542/peds.2006-1347. |
| 11310478 | Background | Desmeules JA. The tramadol option. Eur J Pain. 2000;4 Suppl A:15-21. |
| Background | Dorn MT FN, Quinn FB. Tonsillitis, Tonsillectomy, and Adenoidectomy. Grand Rounds, UTMB - Department of Otolaryngology. December 1999. |
| Background | Drake A CM. Tonsillectomy. EMedicine2003. Available at: http://www.emedicine.com/ent/topic315.htm. |
| 19692147 | Background | Drendel AL, Gorelick MH, Weisman SJ, Lyon R, Brousseau DC, Kim MK. A randomized clinical trial of ibuprofen versus acetaminophen with codeine for acute pediatric arm fracture pain. Ann Emerg Med. 2009 Oct;54(4):553-60. doi: 10.1016/j.annemergmed.2009.06.005. Epub 2009 Aug 19. |
| 12641688 | Background | Engelhardt T, Steel E, Johnston G, Veitch DY. Tramadol for pain relief in children undergoing tonsillectomy: a comparison with morphine. Paediatr Anaesth. 2003 Mar;13(3):249-52. doi: 10.1046/j.1460-9592.2003.00983.x. |
| 12032009 | Background | Finkel JC, Rose JB, Schmitz ML, Birmingham PK, Ulma GA, Gunter JB, Cnaan A, Cote CJ, Medve RA, Schreiner MS. An evaluation of the efficacy and tolerability of oral tramadol hydrochloride tablets for the treatment of postsurgical pain in children. Anesth Analg. 2002 Jun;94(6):1469-73, table of contents. doi: 10.1097/00000539-200206000-00017. |
| Background | Fortier MM, J; Martin, S; Kain, Z. Children's pain at home following ambulatory surgery. J Pain2009;10(4 (Suppl1)):106. |
| 15777107 | Background | Hain RD, Miser A, Devins M, Wallace WH. Strong opioids in pediatric palliative medicine. Paediatr Drugs. 2005;7(1):1-9. doi: 10.2165/00148581-200507010-00001. |
| 11427329 | Background | Hicks CL, von Baeyer CL, Spafford PA, van Korlaar I, Goodenough B. The Faces Pain Scale-Revised: toward a common metric in pediatric pain measurement. Pain. 2001 Aug;93(2):173-183. doi: 10.1016/S0304-3959(01)00314-1. |
| 16719881 | Background | Hullett BJ, Chambers NA, Pascoe EM, Johnson C. Tramadol vs morphine during adenotonsillectomy for obstructive sleep apnea in children. Paediatr Anaesth. 2006 Jun;16(6):648-53. doi: 10.1111/j.1460-9592.2005.01827.x. |
| 15870139 | Background | Marquardt KA, Alsop JA, Albertson TE. Tramadol exposures reported to statewide poison control system. Ann Pharmacother. 2005 Jun;39(6):1039-44. doi: 10.1345/aph.1E577. Epub 2005 May 3. |
| 8783307 | Background | McGrath PA, Seifert CE, Speechley KN, Booth JC, Stitt L, Gibson MC. A new analogue scale for assessing children's pain: an initial validation study. Pain. 1996 Mar;64(3):435-443. doi: 10.1016/0304-3959(95)00171-9. |
| 18562251 | Background | McGrath PJ, Walco GA, Turk DC, Dworkin RH, Brown MT, Davidson K, Eccleston C, Finley GA, Goldschneider K, Haverkos L, Hertz SH, Ljungman G, Palermo T, Rappaport BA, Rhodes T, Schechter N, Scott J, Sethna N, Svensson OK, Stinson J, von Baeyer CL, Walker L, Weisman S, White RE, Zajicek A, Zeltzer L; PedIMMPACT. Core outcome domains and measures for pediatric acute and chronic/recurrent pain clinical trials: PedIMMPACT recommendations. J Pain. 2008 Sep;9(9):771-83. doi: 10.1016/j.jpain.2008.04.007. Epub 2008 Jun 17. |
| 9241658 | Background | McLellan RA, Oscarson M, Seidegard J, Evans DA, Ingelman-Sundberg M. Frequent occurrence of CYP2D6 gene duplication in Saudi Arabians. Pharmacogenetics. 1997 Jun;7(3):187-91. doi: 10.1097/00008571-199706000-00003. |
| 11081593 | Background | Moir MS, Bair E, Shinnick P, Messner A. Acetaminophen versus acetaminophen with codeine after pediatric tonsillectomy. Laryngoscope. 2000 Nov;110(11):1824-7. doi: 10.1097/00005537-200011000-00011. |
| 9150293 | Background | Moore A, Collins S, Carroll D, McQuay H. Paracetamol with and without codeine in acute pain: a quantitative systematic review. Pain. 1997 Apr;70(2-3):193-201. doi: 10.1016/s0304-3959(96)03319-2. |
| 9085303 | Background | Moore AR, McQuay JH. Single-patient data meta-analysis of 3453 postoperative patients: oral tramadol versus placebo, codeine and combination analgesics. Pain. 1997 Feb;69(3):287-294. doi: 10.1016/S0304-3959(96)03291-5. |
| 10888995 | Background | Nunez DA, Provan J, Crawford M. Postoperative tonsillectomy pain in pediatric patients: electrocautery (hot) vs cold dissection and snare tonsillectomy--a randomized trial. Arch Otolaryngol Head Neck Surg. 2000 Jul;126(7):837-41. doi: 10.1001/archotol.126.7.837. |
| Background | Oxford Pain Site. Available at: http://www.medicine.oc.ac.uk/bandolier/booth/painpag/acute.html |
| 11029125 | Background | Pendeville PE, Von Montigny S, Dort JP, Veyckemans F. Double-blind randomized study of tramadol vs. paracetamol in analgesia after day-case tonsillectomy in children. Eur J Anaesthesiol. 2000 Sep;17(9):576-82. doi: 10.1046/j.1365-2346.2000.00729.x. |
| 12505927 | Background | Rose JB, Finkel JC, Arquedas-Mohs A, Himelstein BP, Schreiner M, Medve RA. Oral tramadol for the treatment of pain of 7-30 days' duration in children. Anesth Analg. 2003 Jan;96(1):78-81, table of contents. doi: 10.1097/00000539-200301000-00016. |
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| 15970918 | Background | Sutters KA, Miaskowski C, Holdridge-Zeuner D, Waite S, Paul SM, Savedra MC, Lanier B. Time-contingent dosing of an opioid analgesic after tonsillectomy does not increase moderate-to-severe side effects in children. Pain Manag Nurs. 2005 Jun;6(2):49-57. doi: 10.1016/j.pmn.2005.01.001. |
| 19359097 | Background | von Baeyer CL, Spagrud LJ, McCormick JC, Choo E, Neville K, Connelly MA. Three new datasets supporting use of the Numerical Rating Scale (NRS-11) for children's self-reports of pain intensity. Pain. 2009 Jun;143(3):223-227. doi: 10.1016/j.pain.2009.03.002. Epub 2009 Apr 8. |
| 12453926 | Background | Williams DG, Patel A, Howard RF. Pharmacogenetics of codeine metabolism in an urban population of children and its implications for analgesic reliability. Br J Anaesth. 2002 Dec;89(6):839-45. doi: 10.1093/bja/aef284. |
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). |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Tramadol Suspension | 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). |
|
|
| Secondary | Number of Participants Reporting Side Effects During the Post-tonsillectomy Recovery Period. | Parent-reported side effects entered in 10-day diary. | Posted | Number | participants | Side effects will be observed and recorded daily by caregivers for a total of 10 days in the take-home diary. |
|
|
|
| 1 |
| 42 |
| 33 |
| 38 |
| EG001 | Tramadol Suspension | 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). | 1 | 42 | 35 | 36 |
|
| Throat pain requiring hospitalization | General disorders | Non-systematic Assessment | 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. |
|
| Dehydration | General disorders | Non-systematic Assessment | 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. |
|
| Difficulty with oral intake | Gastrointestinal disorders | Non-systematic Assessment | 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. |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Fever | Infections and infestations | Systematic Assessment |
|
| Itching | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Sweating | General disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Oversedation | General disorders | Systematic Assessment |
|
| Tonsil bleed | Blood and lymphatic system disorders | Systematic Assessment |
|
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| D009057 |
| Stomatognathic Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006571 |
| Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D004472 | Health Care Economics and Organizations |
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D004123 | Dimethylamines |
| D008744 | Methylamines |
| D008055 | Lipids |
| Fever |
|
| Itching |
|
| Rash |
|
| Sweating |
|
| Dizziness |
|
| Headache |
|
| Constipation |
|
| Oversedation |
|
| Tonsil bleed |
|