The Korean Journal of Pain

  • 제35권3호
  • /
  • Pages.311-318
  • /
  • 2022
  • /
  • 2005-9159(pISSN)
  • /
  • 2093-0569(eISSN)
대한통증학회 (The Korean Pain Society)
권호 표지
DOI QR코드

DOI QR Code

Efficacy and safety of low dose oral ketamine for controlling pain and distress during intravenous cannulation in children: a double-blind, randomized, placebo-controlled trial

  • Bagheri, Mahdi (Department of Clinical Pharmacy, School of Pharmacy & Pharmaceutical Sciences, Tehran University of Medical Sciences) ;
  • Soltani, Alireza Ebrahim (Pediatrics Center of Excellence, Children's Medical Center, Tehran University of Medical Sciences) ;
  • Qorbani, Mostafa (Non-communicable Diseases Research Center, Alborz University of Medical Sciences) ;
  • Sureda, Antoni (Research Group in Community Nutrition and Oxidative Stress and Health Research Institute of the Balearic Islands (IdISBa), University of Balearic Islands) ;
  • Faghihi, Toktam (Department of Clinical Pharmacy, School of Pharmacy & Pharmaceutical Sciences, Tehran University of Medical Sciences)
  • 투고 : 2022.01.13
  • 심사 : 2022.03.17
  • 발행 : 2022.07.01
PDF 다운로드
⟨ 이전 논문 다음 논문 ⟩

초록

Background: Ketamine is widely used in infants and young children for procedural sedation and anesthesia. The aim of this study was to evaluate the efficacy and safety of low dose oral ketamine to control pain and distress in children during intravenous (IV) cannulation. Methods: This is a prospective, randomized, double-blind study, including children aged between 3 and 6 years requiring a non-emergent IV-line placement. Children were randomly assigned to two groups, treated either with oral ketamine or a placebo. All patients were monitored for vital signs. Pain was assessed using the Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) and Wong-Baker Faces Pain Rating Scale (WBFS) scales and sedation using a 5-point sedation score. The facility of IV-line placement was measured by a 3-point scale. Adverse effects were recorded after 1 and 24 hours. Results: A total of 79 and 81 children were entered in the ketamine and placebo groups, respectively. The heart and respiratory rates increased significantly in the placebo group. The median CHEOPS 4 (95% confidence interval [CI]: 3, 4, P < 0.001) and WBFS 6 (95% CI: 4, 6, P < 0.001) scores decreased statistically in the ketamine group. IV-line placement was 50% easier in the ketamine group (95% CI: 37%, 63%, P < 0.001). No serious adverse effects were observed in all cases. Conclusions: Low dose oral ketamine effectively decreased the pain and distress during IV cannulation in children without any significant adverse reactions.

키워드

과제정보

The authors tend to thank Ms. Masoumeh Bagheri for assistance with the manuscript, Ms. Fahimeh Rabbani and Ms. Masoumeh Sedaghat for preparation of the medication, randomization of the patients and IV cannulation and also all the staff who aided the study.

참고문헌

  1. Blount RL, Piira T, Cohen LL, Cheng PS. Pediatric procedural pain. Behav Modif 2006; 30: 24-49. https://doi.org/10.1177/0145445505282438
  2. Krauss B, Green SM. Procedural sedation and analgesia in children. Lancet 2006; 367: 766-80. https://doi.org/10.1016/S0140-6736(06)68230-5
  3. Fradet C, McGrath PJ, Kay J, Adams S, Luke B. A prospective survey of reactions to blood tests by children and adolescents. Pain 1990; 40: 53-60. https://doi.org/10.1016/0304-3959(90)91050-S
  4. Green SM, Krauss B. Clinical practice guideline for emergency department ketamine dissociative sedation in children. Ann Emerg Med 2004; 44: 460-71. https://doi.org/10.1016/j.annemergmed.2004.06.006
  5. Green SM, Rothrock SG, Harris T, Hopkins GA, Garrett W, Sherwin T. Intravenous ketamine for pediatric sedation in the emergency department: safety profile with 156 cases. Acad Emerg Med 1998; 5: 971-6. https://doi.org/10.1111/j.1553-2712.1998.tb02773.x
  6. Green SM, Rothrock SG, Lynch EL, Ho M, Harris T, Hestdalen R, et al. Intramuscular ketamine for pediatric sedation in the emergency department: safety profile in 1,022 cases. Ann Emerg Med 1998; 31: 688-97. https://doi.org/10.1016/S0196-0644(98)70226-4
  7. Sherwin TS, Green SM, Khan A, Chapman DS, Dannenberg B. Does adjunctive midazolam reduce recovery agitation after ketamine sedation for pediatric procedures? A randomized, double-blind, placebo-controlled trial. Ann Emerg Med 2000; 35: 229-38. https://doi.org/10.1016/S0196-0644(00)70073-4
  8. Sotoodehnia M, Farmahini-Farahani M, Safaie A, Rasooli F, Baratloo A. Low-dose intravenous ketamine versus intravenous ketorolac in pain control in patients with acute renal colic in an emergency setting: a double-blind randomized clinical trial. Korean J Pain 2019; 32: 97-104. https://doi.org/10.3344/kjp.2019.32.2.97
  9. Svenson JE, Abernathy MK. Ketamine for prehospital use: new look at an old drug. Am J Emerg Med 2007; 25: 977-80. https://doi.org/10.1016/j.ajem.2007.02.040
  10. Pasero C, McCaffery M. Pain control: ketamine: low doses may provide relief for some painful conditions. Am J Nurs 2005; 105: 60-4. https://doi.org/10.1097/00000446-200504000-00028
  11. Oyedepo OO, Nasir AA, Abdur-Rahman LO, Kolawole IK, Bolaji BO, Ige OA. Efficacy and safety of oral ketamine premedication in children undergoing day case surgery. J West Afr Coll Surg 2016; 6: 1-15.
  12. Gutstein HB, Johnson KL, Heard MB, Gregory GA. Oral ketamine preanesthetic medication in children. Anesthesiology 1992; 76: 28-33. https://doi.org/10.1097/00000542-199201000-00004
  13. Rostaminezhad A, Raeis KF, Zandi GK. A study on oral ketamine premedication effects on preparation of children for surgery. Armaghane Danesh 2001; 6: 1-7.
  14. Oriby ME. Comparison of intranasal dexmedetomidine and oral ketamine versus intranasal midazolam premedication for children undergoing dental rehabilitation. Anesth Pain Med 2019; 9: e8522.
  15. Soleimanpour H, Mahmoodpoor A, Eftekhari Milani F, Shahsavari Nia K, Mehdizadeh Esfanjani R, Safari S. Effectiveness of oral ketamine, midazolam, and atropine cocktail versus oral diphenhydramine for pediatric sedation in the emergency department. Iran Red Crescent Med J 2014; 16: e21366. https://doi.org/10.5812/ircmj.21366
  16. Kamel AAF, Amin OAI. Analgo-sedative effects of oral or nebulized ketamine in preschoolers undergoing elective surgery: a comparative, randomized, double-blind study. Pain Physician 2020; 23: E195-202. https://doi.org/10.36076/ppj.2020/23/E195
  17. Majidinejad S, Taherian K, Esmailian M, Khazaei M, Samaie V. Oral midazolam-ketamine versus midazolam alone for procedural sedation of children undergoing computed tomography; a randomized clinical trial. Emerg (Tehran) 2015; 3: 64-9.
  18. Sekerci C, Donmez A, AteS Y, Okten F. Oral ketamine premedication in children (placebo controlled double-blind study). Eur J Anaesthesiol 1996; 13: 606-11. https://doi.org/10.1046/j.1365-2346.1996.00058.x
  19. Kurdi MS, Theerth KA, Deva RS. Ketamine: Current applications in anesthesia, pain, and critical care. Anesth Essays Res 2014; 8: 283-90. https://doi.org/10.4103/0259-1162.143110
  20. Kimiaei Asadi H, Nikooseresht M, Noori L, Behnoud F. The effect of administration of ketamine and paracetamol versus paracetamol singly on postoperative pain, nausea and vomiting after pediatric adenotonsillectomy. Anesth Pain Med 2016; 6: e31210. https://doi.org/10.5812/aapm.31210
  21. Barkan S, Breitbart R, Brenner-Zada G, Feldon M, Assa A, Toledano M, et al. A double-blind, randomised, placebo-controlled trial of oral midazolam plus oral ketamine for sedation of children during laceration repair. Emerg Med J 2014; 31: 649-53. https://doi.org/10.1136/emermed-2012-202189
  22. Funk W, Jakob W, Riedl T, Taeger K. Oral preanaesthetic medication for children: double-blind randomized study of a combination of midazolam and ketamine vs midazolam or ketamine alone. Br J Anaesth 2000; 84: 335-40. https://doi.org/10.1093/oxfordjournals.bja.a013435
  23. Turhanoglu S, Kararmaz A, Ozyilmaz MA, Kaya S, Tok D. Effects of different doses of oral ketamine for premedication of children. Eur J Anaesthesiol 2003; 20: 56-60. https://doi.org/10.1017/s0265021503000103
  24. Horiuchi T, Kawaguchi M, Kurehara K, Kawaraguchi Y, Sasaoka N, Furuya H. Evaluation of relatively low dose of oral transmucosal ketamine premedication in children: a comparison with oral midazolam. Paediatr Anaesth 2005; 15: 643-7. https://doi.org/10.1111/j.1460-9592.2004.01513.x
  25. Javid MJ, Hajijafari M, Hajipour A, Makarem J, Khazaeipour Z. Evaluation of a low dose ketamine in post tonsillectomy pain relief: a randomized trial comparing intravenous and subcutaneous ketamine in pediatrics. Anesth Pain Med 2012; 2: 85-9. https://doi.org/10.5812/aapm.4399
  26. Hatton RC, Patel J, Low MW, Ganesh O. Use of oral ketamine by academic hospitals in the US. Ann Pharmacother 2013; 47: 591-2. https://doi.org/10.1345/aph.1S019
  27. Kalra P. Miller's anesthesia, volumes 1 and 2, 7th edition. Anesthesiology 2010; 112: 260-1. https://doi.org/10.1097/ALN.0b013e3181c5dc06
  28. Kubota R, Komiyama T, Miwa Y, Bun S, Ishii J, Minei S, et al. Pharmacokinetics of ketamine and norketamine after oral administration of a liquid formulation of ketamine. J Curr Surg 2013; 3: 82-6.
  29. Soto E, Stewart DR, Mannes AJ, Ruppert SL, Baker K, Zlott D, et al. Oral ketamine in the palliative care setting: a review of the literature and case report of a patient with neurofibromatosis type 1 and glomus tumor-associated complex regional pain syndrome. Am J Hosp Palliat Care 2012; 29: 308-17. https://doi.org/10.1177/1049909111416345
  30. Ozdemir D, Kayserili E, Arslanoglu S, Gulez P, Vergin C. Ketamine and midazolam for invasive procedures in children with malignancy: a comparison of routes of intravenous, oral, and rectal administration. J Trop Pediatr 2004; 50: 224-8. https://doi.org/10.1093/tropej/50.4.224
  31. Ketamine (Rx). Medscape Reference [Internet]. New York (NY): Medscape; 2022. Available at: https://reference.medscape.com/drug/ketalar-ketamine-343099.
  32. Tobias JD, Phipps S, Smith B, Mulhern RK. Oral ketamine premedication to alleviate the distress of invasive procedures in pediatric oncology patients. Pediatrics 1992; 90: 537-41. https://doi.org/10.1542/peds.90.4.537
  33. Beebe DS, Belani KG, Chang PN, Hesse PS, Schuh JS, Liao JC, et al. Effectiveness of preoperative sedation with rectal midazolam, ketamine, or their combination in young children. Anesth Analg 1992; 75: 880-4.
  34. Narendra PL, Naphade RW, Nallamilli S, Mohd S. A comparison of intranasal ketamine and intranasal midazolam for pediatric premedication. Anesth Essays Res 2015; 9: 213-8. https://doi.org/10.4103/0259-1162.154051
  35. Motamed F, Aminpour Y, Hashemian H, Soltani AE, Najafi M, Farahmand F. Midazolam-ketamine combination for moderate sedation in upper GI endoscopy. J Pediatr Gastroenterol Nutr 2012; 54: 422-6. https://doi.org/10.1097/MPG.0b013e3182323c75
  36. Norambuena C, Yanez J, Flores V, Puentes P, Carrasco P, Villena R. Oral ketamine and midazolam for pediatric burn patients: a prospective, randomized, double-blind study. J Pediatr Surg 2013; 48: 629-34. https://doi.org/10.1016/j.jpedsurg.2012.08.018
  37. Qureshi FA, Mellis PT, McFadden MA. Efficacy of oral ketamine for providing sedation and analgesia to children requiring laceration repair. Pediatr Emerg Care 1995; 11: 93-7. https://doi.org/10.1097/00006565-199504000-00009
  38. Jain K, Ghai B, Saxena AK, Saini D, Khandelwal N. Efficacy of two oral premedicants: midazolam or a low-dose combination of midazolam-ketamine for reducing stress during intravenous cannulation in children undergoing CT imaging. Paediatr Anaesth 2010; 20: 330-7. https://doi.org/10.1111/j.1460-9592.2010.03279.x
  39. Green SM, Johnson NE. Ketamine sedation for pediatric procedures: part 2, review and implications. Ann Emerg Med 1990; 19: 1033-46. https://doi.org/10.1016/S0196-0644(05)82569-7
  40. Petrack EM. Ketamine. Clin Pediatr Emerg Med 2000; 1: 281-4. https://doi.org/10.1016/S1522-8401(00)90041-7
  41. Visintainer MA, Wolfer JA. Psychological preparation for surgery pediatric patients: the effects on children's and parents' stress responses and adjustment. Pediatrics 1975; 56: 187-202. https://doi.org/10.1542/peds.56.2.187
  42. Schechter NL, Weisman SJ, Rosenblum M, Bernstein B, Conard PL. The use of oral transmucosal fentanyl citrate for painful procedures in children. Pediatrics 1995; 95: 335-9.
  43. Saarnivaara L, Lindgren L, Klemola UM. Comparison of chloral hydrate and midazolam by mouth as premedicants in children undergoing otolaryngological surgery. Br J Anaesth 1988; 61: 390-6. https://doi.org/10.1093/bja/61.4.390
  44. Kil HK, Kim WO, Han SW, Kwon Y, Lee A, Hong JY. Psychological and behavioral effects of chloral hydrate in day-case pediatric surgery: a randomized, observer-blinded study. J Pediatr Surg 2012; 47: 1592-9. https://doi.org/10.1016/j.jpedsurg.2011.12.025
  45. Hamid M, Khan MA, Khatri A, Akhtar I. Effectiveness of premedication at the time of separation from parent and mask induction in paediatric patients coming for congenital heart disease surgery. J Coll Physicians Surg Pak 2012; 22: 280-4.
  46. Sajid B, Mohamed T, Jumaila M. A comparison of oral dexmedetomidine and oral midazolam as premedicants in children. J Anaesthesiol Clin Pharmacol 2019; 35: 36-40. https://doi.org/10.4103/joacp.JOACP_20_18
  47. Kim KH. Safe sedation and hypnosis using dexmedetomidine for minimally invasive spine surgery in a prone position. Korean J Pain 2014; 27: 313-20. https://doi.org/10.3344/kjp.2014.27.4.313