International Journal of Anesthesia and Clinical Medicine

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An Audit of Perioperative Use of Tramadol in Children in a Specialized Children Hospital

Received: 24 May 2020    Accepted: 08 June 2020    Published: 16 June 2020
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Abstract

Background: Tramadol is widely used worldwide to treat moderate to severe pain in children. There are growing concerns regarding the safety of tramadol use in children in recent years when the US FDA (Food and Drug Administration) issued a safety announcement that restricts tramadol use in children less than 18 years old to treat pain after tonsillectomy and adenoidectomy. After this FDA announcement, our hospital stopped using tramadol in children less than 18 years old. Objective: we planned to audit our experience in the use of intravenous tramadol in children for postoperative pain management in recovery area. Methods: Institutional Review Board (IRB) waived written informed consent. After getting the IRB approval, we reviewed the anesthesia records of 16130 patients between the years 2015 and 2017. We looked for patients who received tramadol postoperatively in PACU (post-anesthesia care unit). We looked for postoperative complications or adverse events in the form of apnea, hypopnea, bradycardia, postoperative nausea and vomiting, prolonged stay in recovery, unplanned admission, or admission after discharge within 48 hours. Statistical analysis was done using Wilcoxon scores for variables, Wilcoxon 2 sample test, calculated odd's Ratio and 95% confidence interval and P-values where P values less than 0.05 were considered significant. Results: Seven patients desaturated out of 430 patients. They needed oxygen support in the form of simple facemask or nasal cannula but no one needed positive pressure ventilation. No one developed apnea or bradycardia or needed naloxone administration. There was no readmission after discharge from the hospital. There was only one unplanned admission due to a surgical cause. The average duration of stay in the PACU was 86 minutes. Almost all (418) patients stayed more than 45 min (97.2%). Ninety-two patients had PONV (postoperative nausea and vomiting) (21.39%). There was positive correlation between PONV and total tramadol dose, while a comparison of the Pearson correlations showed that duration of the procedure was the best predictor of PACU duration with an R-value of 0.188 which was highly significant at the P<0.0001. Conclusion: Tramadol does not cause respiratory depression in children, especially when given in a controlled and monitored setup in the operating room and recovery area however Still, Tramadol needs to be studied more in pediatric anesthesia and analgesia and more comparative data is required to determine the safety of available opioids in this setting.

DOI 10.11648/j.ijacm.20200802.11
Published in International Journal of Anesthesia and Clinical Medicine (Volume 8, Issue 2, December 2020)
Page(s) 30-36
Creative Commons

This is an Open Access article, distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution and reproduction in any medium or format, provided the original work is properly cited.

Copyright

Copyright © The Author(s), 2024. Published by Science Publishing Group

Keywords

Intravenous Tramadol, Peri-operative Pain, Pediatric Anesthesia, Postoperative Analgesia

References
[1] U.S. Food and Drug Administration. (2017). FDA warns against use of codeine and tramadol in children and breastfeeding women. Med Lett Drugs Ther; 59: 86-8.
[2] U.S. Food and Drug Administration. (2013). Safety review update of codeine use in children; new boxed warning and contraindication on use after tonsillectomy and/or adenoidectomy. Silver Spring, MD: Author. Retrieved from https://www.fda.gov/downloads/drugs/drugsafety/ucm339116.pdf.
[3] U.S. Food and Drug Administration. (2017). FDA restricts use of prescription codeine pain and cough medicines and tramadol pain medicines in children. Silver Spring, MD: Author. Retrieved from https://www.fda.gov/Drugs/DrugSafety/ucm549679.htm.
[4] Dilip, D. S. and Zubair H. S. (2020). Tramadol/Diclofenac Fixed-Dose Combination: A Review of Its Use in Severe Acute Pain. Pain Ther; 9 (1): 113–128. doi: 10.1007/s40122-020-00155-7.
[5] Shipton EA. (2000) Tramadol-present and future. Anaesth Intensive Care; 28: 363–74.
[6] Orliaguet G, Hamza J, Couloigner V, Denoyelle F, Loriot MA, Broly F, et al.( 2015). A case of respiratory depression in a child with ultra-rapid CYP2D6 metabolism after tramadol. Pediatrics; 135: e753-5.
[7] Salvo I, Landoni G, Mucchetti M, Cabrini L, Pani L. (2014). Use and reimbursement of off-label drugs in pediatric anesthesia: the Italian experience. Pediatric Anesthesia; 24: 625–31.
[8] Aschenbrenner D. S. (2017). Codeine and tramadol contraindicated for pediatric use. Am J Nurs; 117, 8: 23.
[9] Gina L. S., Lawrence G., Wendy K. S. (2019). Characterizing the Toxicity and Dose-Effect Profile of Tramadol Ingestions in Children. Pediatr Emerg Care; 35 (2): 117-120.
[10] Brian J. A., Jane T., Kaye O., George A. C. (2017). Tramadol: keep calm and carry on. Pediatric Anesthesia; 27: 785–788. DOI: 10.1111/pan.13190.
[11] Hossein H. M., Fariba F., and Mitra R. (2015). Tramadol overdose and apnea in hospitalized children, a review of 20 cases. Res Pharm Sci; 10 (6): 544–552. PMCID: PMC4698865.
[12] Neri, E., Maestro, A., Minen, F., Montico, M., Ronfani, L., Zanon, D., et al. (2013). Sublingual ketorolac versus sublingual tramadol for moderate to severe posttraumatic bone pain in children: a double blind, randomized, controlled trial. Arch. Dis. Child; 98: 721-24.
[13] Friedrichsdorf S. J., Postier, A. C., Foster, L. P., Lander, T. A., Tibesar, R. J., Lu, Y., et al. (2015). Tramadol versus codeine/acetaminophen after pediatric tonsillectomy: a prospective, double-blinded, randomized controlled trial. J. Opioid Manag; 11: 283-94.
[14] Erhan E, Inal M. T., Aydinok Y, Balkan C, and Yegul I. (2007). Tramadol infusion for the pain management in sickle cell disease: a case report. Paediatr. Anaesth; 17: 84-6.
[15] Borgerding M. P, Absher R. K., and So T. Y. (2013). Tramadol use in pediatric sickle cell disease patients with vaso-occlusive crisis. World J Clin Pediatr; 8: 65-9.
[16] Hullett B. J., Chambers N. A., Pascoe E. M. and Johnson C. (2006). Tramadol vs morphine during adenotonsillectomy for obstructive sleep apnea in children. Pediatric Anesth; 16: 648-53.
[17] The Children’s Clinic. (2017). Do not use codeine, tramadol in children: FDA. News Content Editor, Melissa J., AAP News.
[18] http://www.spanza.org.au/images/17_05_SPANZA_Advisory_on_Tramadol_31_May_2017.pdf SPANZA’s statement on the use of Tramadol in children having tonsillectomy under the age of 18 years in May 2017 in response to the new FDA contraindication.
[19] Rodieux F, Vutskits L, Posfay-Barbe K. M., Habre W, Piguet V, Desmeules J. A., Samer C. F. (2018). When the Safe Alternative Is Not That Safe: Tramadol Prescribing in Children. Front Pharmacol; 9: 148.
[20] Hansen TG. (2017). Use of anaesthetics in young children: Consensus statement of the European Society of Anaesthesiology, the European Society for Paediatric Anaesthesiology, the European Association of Cardiothoracic Anaesthesiology; 34: 327-28.
[21] http://www.spanza.org.au/images/15_06_SPANZA_Advisory_on_Tramadol_June_2017.pdf SPANZA’s statement on the Use of Tramadol during breastfeeding and in the Neonate in June 2017 in response to the new FDA contraindication.
Author Information
  • Pediatric Anesthesia Department, King Abdullah Specialized Children’s Hospital, Riyadh, Saudi Arabia

  • Pediatric Anesthesia Department, King Abdullah Specialized Children’s Hospital, Riyadh, Saudi Arabia; Department of Anesthesia and Intensive Care, Ain Shams University, Cairo, Egypt

  • Pediatric Anesthesia Department, King Abdullah Specialized Children’s Hospital, Riyadh, Saudi Arabia; Department of Anesthesia, King Abdulaziz Medical City, Riyadh, Saudi Arabia

  • Pediatric Anesthesia Department, King Abdullah Specialized Children’s Hospital, Riyadh, Saudi Arabia; Department of Anesthesia and Intensive Care, Cairo University, Cairo, Egypt

  • Pediatric Anesthesia Department, King Abdullah Specialized Children’s Hospital, Riyadh, Saudi Arabia

  • Pediatric Anesthesia Department, King Abdullah Specialized Children’s Hospital, Riyadh, Saudi Arabia

  • Department of Anesthesia, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia

  • Department of Anesthesia, Armed Forces Medical Services, Muscat, Sultanate of Oman

  • Department of Anesthesia, King Abdulaziz Medical City, Riyadh, Saudi Arabia

  • Department of Biostatistics and Bioinformatics, King Abdullah International Medical Research Center, Riyadh, Saudi Arabia; Department of Biostatistics and Bioinformatics, King Saud bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia

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  • APA Style

    Ahmed Haroun Mahmoud, Mohamed Hanafi Mahmoud, Abdulaleem Alatassi, Mohamed Ibrahim Emam, Ahmed Mahran Hamada, et al. (2020). An Audit of Perioperative Use of Tramadol in Children in a Specialized Children Hospital. International Journal of Anesthesia and Clinical Medicine, 8(2), 30-36. https://doi.org/10.11648/j.ijacm.20200802.11

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    ACS Style

    Ahmed Haroun Mahmoud; Mohamed Hanafi Mahmoud; Abdulaleem Alatassi; Mohamed Ibrahim Emam; Ahmed Mahran Hamada, et al. An Audit of Perioperative Use of Tramadol in Children in a Specialized Children Hospital. Int. J. Anesth. Clin. Med. 2020, 8(2), 30-36. doi: 10.11648/j.ijacm.20200802.11

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    AMA Style

    Ahmed Haroun Mahmoud, Mohamed Hanafi Mahmoud, Abdulaleem Alatassi, Mohamed Ibrahim Emam, Ahmed Mahran Hamada, et al. An Audit of Perioperative Use of Tramadol in Children in a Specialized Children Hospital. Int J Anesth Clin Med. 2020;8(2):30-36. doi: 10.11648/j.ijacm.20200802.11

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  • @article{10.11648/j.ijacm.20200802.11,
      author = {Ahmed Haroun Mahmoud and Mohamed Hanafi Mahmoud and Abdulaleem Alatassi and Mohamed Ibrahim Emam and Ahmed Mahran Hamada and Marwan Hadaki and Zainab Alzayer and Badar Alhasani and Abdulrahman Aljamous and Husam I. Ardah},
      title = {An Audit of Perioperative Use of Tramadol in Children in a Specialized Children Hospital},
      journal = {International Journal of Anesthesia and Clinical Medicine},
      volume = {8},
      number = {2},
      pages = {30-36},
      doi = {10.11648/j.ijacm.20200802.11},
      url = {https://doi.org/10.11648/j.ijacm.20200802.11},
      eprint = {https://download.sciencepg.com/pdf/10.11648.j.ijacm.20200802.11},
      abstract = {Background: Tramadol is widely used worldwide to treat moderate to severe pain in children. There are growing concerns regarding the safety of tramadol use in children in recent years when the US FDA (Food and Drug Administration) issued a safety announcement that restricts tramadol use in children less than 18 years old to treat pain after tonsillectomy and adenoidectomy. After this FDA announcement, our hospital stopped using tramadol in children less than 18 years old. Objective: we planned to audit our experience in the use of intravenous tramadol in children for postoperative pain management in recovery area. Methods: Institutional Review Board (IRB) waived written informed consent. After getting the IRB approval, we reviewed the anesthesia records of 16130 patients between the years 2015 and 2017. We looked for patients who received tramadol postoperatively in PACU (post-anesthesia care unit). We looked for postoperative complications or adverse events in the form of apnea, hypopnea, bradycardia, postoperative nausea and vomiting, prolonged stay in recovery, unplanned admission, or admission after discharge within 48 hours. Statistical analysis was done using Wilcoxon scores for variables, Wilcoxon 2 sample test, calculated odd's Ratio and 95% confidence interval and P-values where P values less than 0.05 were considered significant. Results: Seven patients desaturated out of 430 patients. They needed oxygen support in the form of simple facemask or nasal cannula but no one needed positive pressure ventilation. No one developed apnea or bradycardia or needed naloxone administration. There was no readmission after discharge from the hospital. There was only one unplanned admission due to a surgical cause. The average duration of stay in the PACU was 86 minutes. Almost all (418) patients stayed more than 45 min (97.2%). Ninety-two patients had PONV (postoperative nausea and vomiting) (21.39%). There was positive correlation between PONV and total tramadol dose, while a comparison of the Pearson correlations showed that duration of the procedure was the best predictor of PACU duration with an R-value of 0.188 which was highly significant at the P<0.0001. Conclusion: Tramadol does not cause respiratory depression in children, especially when given in a controlled and monitored setup in the operating room and recovery area however Still, Tramadol needs to be studied more in pediatric anesthesia and analgesia and more comparative data is required to determine the safety of available opioids in this setting.},
     year = {2020}
    }
    

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  • TY  - JOUR
    T1  - An Audit of Perioperative Use of Tramadol in Children in a Specialized Children Hospital
    AU  - Ahmed Haroun Mahmoud
    AU  - Mohamed Hanafi Mahmoud
    AU  - Abdulaleem Alatassi
    AU  - Mohamed Ibrahim Emam
    AU  - Ahmed Mahran Hamada
    AU  - Marwan Hadaki
    AU  - Zainab Alzayer
    AU  - Badar Alhasani
    AU  - Abdulrahman Aljamous
    AU  - Husam I. Ardah
    Y1  - 2020/06/16
    PY  - 2020
    N1  - https://doi.org/10.11648/j.ijacm.20200802.11
    DO  - 10.11648/j.ijacm.20200802.11
    T2  - International Journal of Anesthesia and Clinical Medicine
    JF  - International Journal of Anesthesia and Clinical Medicine
    JO  - International Journal of Anesthesia and Clinical Medicine
    SP  - 30
    EP  - 36
    PB  - Science Publishing Group
    UR  - https://doi.org/10.11648/j.ijacm.20200802.11
    AB  - Background: Tramadol is widely used worldwide to treat moderate to severe pain in children. There are growing concerns regarding the safety of tramadol use in children in recent years when the US FDA (Food and Drug Administration) issued a safety announcement that restricts tramadol use in children less than 18 years old to treat pain after tonsillectomy and adenoidectomy. After this FDA announcement, our hospital stopped using tramadol in children less than 18 years old. Objective: we planned to audit our experience in the use of intravenous tramadol in children for postoperative pain management in recovery area. Methods: Institutional Review Board (IRB) waived written informed consent. After getting the IRB approval, we reviewed the anesthesia records of 16130 patients between the years 2015 and 2017. We looked for patients who received tramadol postoperatively in PACU (post-anesthesia care unit). We looked for postoperative complications or adverse events in the form of apnea, hypopnea, bradycardia, postoperative nausea and vomiting, prolonged stay in recovery, unplanned admission, or admission after discharge within 48 hours. Statistical analysis was done using Wilcoxon scores for variables, Wilcoxon 2 sample test, calculated odd's Ratio and 95% confidence interval and P-values where P values less than 0.05 were considered significant. Results: Seven patients desaturated out of 430 patients. They needed oxygen support in the form of simple facemask or nasal cannula but no one needed positive pressure ventilation. No one developed apnea or bradycardia or needed naloxone administration. There was no readmission after discharge from the hospital. There was only one unplanned admission due to a surgical cause. The average duration of stay in the PACU was 86 minutes. Almost all (418) patients stayed more than 45 min (97.2%). Ninety-two patients had PONV (postoperative nausea and vomiting) (21.39%). There was positive correlation between PONV and total tramadol dose, while a comparison of the Pearson correlations showed that duration of the procedure was the best predictor of PACU duration with an R-value of 0.188 which was highly significant at the P<0.0001. Conclusion: Tramadol does not cause respiratory depression in children, especially when given in a controlled and monitored setup in the operating room and recovery area however Still, Tramadol needs to be studied more in pediatric anesthesia and analgesia and more comparative data is required to determine the safety of available opioids in this setting.
    VL  - 8
    IS  - 2
    ER  - 

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