Oral preanesthetic medication in children – comparison between midazolam alone and in combination with ketamine: a systematic review and meta-analysis
Medicação pré-anestésica oral em crianças – comparação entre midazolam isolado e em combinação com cetamina: revisão sistemática e meta-análise
Getúlio Rodrigues de Oliveira Filho; Carlos Maestri Castilhos; Jean Philippe Kriegl; Giulia Nonticuri Bianchi
Abstract
Background
Up to 60% of pediatric surgical patients develop high levels of preoperative anxiety. This study compared the effects of oral combinations of midazolam and ketamine with oral midazolam alone for pediatric preanesthetic medication.
Methods
The study protocol was registered in PROSPERO as CRD42020172920. A systematic literature search was conducted using Medline, Cochrane, EMBASE, CENTRAL, and Web of Science for randomized controlled trials comparing oral combinations of midazolam and ketamine with midazolam alone as preanesthetic medication in elective surgical pediatric patients. Meta-analyses included the following outcomes: anxiety and sedation levels, child’s behavior during separation from parents, face mask acceptance, and venipuncture. The quality of evidence was assessed using GRADE criteria.
Results
Twenty studies were included. The following effects (RR (95% CI)) were observed for combinations of ketamine and midazolam relative midazolam alone: anxiolysis (1.2 (0.94–1.52);p = 0.15; I2 = 80%; GRADE = very low); satisfactory sedation (1.2 ( 1.10–1.31); p < 0.001; I2 = 71%; GRADE = very low); behavior during parental separation (1.2 (1.06–1.36); p = 0.003; I2 = 88%; GRADE = very low); facial mask acceptance (1.13 (1.04–1.24); p = 0.007; I2 = 49%; GRADE = very low); behavior during venipuncture (1.32 (1.11–1.57); p = 0.002; I2 = 66%; GRADE = very low).
Conclusions
While similar probabilities of obtaining anxiolysis were found, adequate sedation, calm behavior during child’s separation from parents, low levels of fear during face mask adaptation, and cooperative behavior during peripheral venous cannulation were more likely with midazolam-ketamine combinations.
Keywords
Resumo
Introdução
Até 60% dos pacientes cirúrgicos pediátricos desenvolvem altos níveis de ansiedade pré-operatória. Este estudo comparou os efeitos de combinações orais de midazolam e cetamina com midazolam oral sozinho para medicação pré-anestésica pediátrica.
Métodos
O protocolo do estudo foi registrado no PROSPERO como CRD42020172920. Uma busca sistemática da literatura foi realizada usando Medline, Cochrane, EMBASE, CENTRAL e Web of Science para ensaios clínicos randomizados comparando combinações orais de midazolam e cetamina com midazolam sozinho como medicação pré-anestésica em pacientes pediátricos cirúrgicos eletivos. As metanálises incluíram os seguintes resultados: níveis de ansiedade e sedação, comportamento da criança durante a separação dos pais, aceitação da máscara facial e punção venosa. A qualidade da evidência foi avaliada usando critérios GRADE.
Resultados
Vinte estudos foram incluídos. Os seguintes efeitos (RR (95% CI)) foram observados para combinações de cetamina e midazolam em relação ao midazolam sozinho: ansiólise (1,2 (0,94–1,52); p = 0,15; I2 = 80%; GRADE = muito baixo); sedação satisfatória (1,2 (1,10–1,31); p < 0,001; I2 = 71%; GRADE = muito baixo); comportamento durante a separação dos pais (1,2 (1,06–1,36); p = 0,003; I2 = 88%; GRADE = muito baixo); aceitação da máscara facial (1,13 (1,04–1,24); p = 0,007; I2 = 49%; GRADE = muito baixo); comportamento durante a punção venosa (1,32 (1,11–1,57); p = 0,002; I2 = 66%; GRADE = muito baixo).
Conclusões
Embora tenham sido encontradas probabilidades semelhantes de obter ansiólise, sedação adequada, comportamento calmo durante a separação da criança dos pais, baixos níveis de medo durante a adaptação da máscara facial e comportamento cooperativo durante a canulação venosa periférica foram mais prováveis com combinações de midazolam-cetamina.
Palavras-chave
References
1. Kain ZN, Mayes LC, O’Connor TZ, et al. Preoperative anxiety in children. Predictors and outcomes. Arch Pediatr Adolesc Med. 1996;150:1238---45.
2. Kain ZN, Mayes LC, Caldwell-Andrews AA, et al. Preoperative anxiety, postoperative pain, and behavioral recovery in young children undergoing surgery. Pediatrics. 2006;118:651---8.
3. Kain ZN, Caldwell-Andrews AA, Maranets I, et al. Preoperative anxiety and emergence delirium and postoperative maladaptive behaviors. Anesth Analg. 2004;99:1648---54.
4. Manyande A, Cyna AM, Yip P, et al. Non-pharmacological interventions for assisting the induction of anaesthesia in children. Cochrane Database Syst Rev. 2015:Cd006447.
5. Funk W, Jakob W, Riedl T, et al. 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.
6. Walia C, Pankaj, Prabhu M, et al. Oral premedication in children: Comparison of combination of midazolam-ketamine and oral midazolam-A Randomised trial. Indian J Clin Anaesth. 2018;5:249---54.
7. Manso MA, Guittet C, Vandenhende F, et al. Efficacy of oral midazolam for minimal and moderate sedation in pediatric patients: A systematic review. Pediatric Anesthesia. 2019;29:1094---106.
8. Gutstein HB, Johnson KL, Heard MB, et al. Oral ketamine preanesthetic medication in children. Anesthesiology. 1992;76:28---33.
9. Moher D, Liberati A, Tetzlaff J, et al. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. PLoS Med. 2009;6:e1000097.
10. U.S. National Institute of Health Research. PROSPERO. International prospective register of systematic reviews. https://www.crd.york.ac.uk/prospero/. Accessed 09/23/2019.
11. Engauge Digitizer Software [computer program]. Version 62015.
12. Sterne JAC, Savovi´c J, Page MJ, et al. RoB 2: a revised tool for assessing risk of bias in randomised trials. Br Med J. 2019;366:l4898.
13. Duval S, Tweedie R. Trim and Fill: A Simple Funnel-Plot---Based Method of Testing and Adjusting for Publication Bias in MetaAnalysis. Biometrics. 2000;56:455---63.
14. Palmer TM, Sutton AJ, Peters JL, et al. Contour-enhanced funnel plots for meta-analysis. Stata J. 2008;8:242---54.
15. Peters JL, Sutton AJ, Jones DR, et al. Contour-enhanced metaanalysis funnel plots help distinguish publication bias from other causes of asymmetry. J Clin Epidemiol. 2008;61:991---6.
16. Mustafa RA, Wiercioch W, Santesso N, et al. Decision-Making about Healthcare Related Tests and Diagnostic Strategies: User Testing of GRADE Evidence Tables. PLoS One. 2015;10:e0134553.
17. Harbord RM, Harris RJ, Sterne JAC. Updated Tests for Smallstudy Effects in Meta-analyses. Stata J. 2009;9:197---210.
18. GRADEpro GDT [computer program]. Hamilton (ON): McMaster University; 2015.
19. Darlong V, Shende D, Singh M, et al. Low-versus high-dose combination of midazolam-ketamine for oral premedication in children for ophthalmologic surgeries. Singapore Med J. 2011;52:512---6.
20. Darlong V, Shende D, Subramanyam MS, et al. Oral ketamine or midazolam or low dose combination for premedication in children. Anaesth Intensive Care. 2004;32:246---9.
21. Foroutan A, Yazdanian F, Panahipour AA, et al. Oral premedication for pediatric cardiac surgery: a comparison of midazolam, ketamine and midazolam plus ketamine. Iran Heart J. 2008;8:17---23.
22. Kulikov AS, Sorokin VS, Lubnin A. Oral premedication with midasolam and ketamine in children with neurosurgical diseases. Anesteziol Reanimatol. 2010:6---10.
23. Magar J, Kotwani MBK, Kotak S. A double blinded comparative study of oral premedication in children with midazolam alone or in combination with ketamine. Int J Contemp Pediatr. 2016; 3:8.
24. Mithun B, Anand B. A comparative study between midazolam, ketamine and combination of both as a premedication in pediatric surgeries. MedPulse Int J Anesthesiol. 2018;6:27---32.
25. Ramakrishna R, Hemanth KJ, Sunil BV, et al. Oral premedication in children: A randomized study of a combination of oral midazolam, ketamine with atropine vs midazolam and atropine vs ketamine and atropine. Indian J Clin Anaesth. 2018;5:261---5.
26. Ghai B, Grandhe RP, Kumar A, et al. Comparative evaluation of midazolam and ketamine with midazolam alone as oral premedication. Paediatr Anaesth. 2005;15:554---9.
27. Hasani M. Comparison Of Oral Premedication With Combination Of Midazolam With Ketamine Vs Midazolam Ketamine Alone In Children Children Medical Center (year 2000). Tehran Univ Med J. 2002;60:423---8.
28. Sajedi P, Aghadavoudi O, Salimi-Jazi F. Oral midazolam alone or in combination with ketamine as oral premedication in pediatric ophthalmologic surgeries. J Isfahan Med Sch. 2014;31:1901---9.
29. Astuto M, Disma N, Crimi E. Two doses of oral ketamine, given with midazolam, for premedication in children. Minerva Anestesiol. 2002;68:593---8.
30. Sathyan N. Comparative Evaluation of Two Doses of Ketamine with Midazolam, Ketamine alone and Midazolam alone as Oral Premedication in Children: A Study of 100 cases. Madurai: Madurai Medical College; 2006.
31. Jain K, Ghai B, Saxena AK, et al. 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.
32. Kumar A, Shah ZA, Anuradha, et al. Comparative evaluation of ketamine, midazolam and combination of both as oral premedicants in children. J Anaesthesiol Clin Pharmacol. 2009;25:449---53.
33. Majidinejad S, Taherian K, Esmailian M, et al. Oral midazolamketamine versus midazolam alone for procedural sedation of children undergoing computed tomography; a randomized clinical trial. Emergency. 2015;3:64---9.
34. Rabie ME. Combination of oral ketamine and midazolam versus midazolam alone as a premedication in children undergoing tonsillectomy. AJAIC. 2005;8:58---64.
35. Lin YC, Moynihan RJ, Hackel A. A comparison of oral midazolam, oral ketamine, and oral midazolam combined with ketamine as preanesthetic medication for pediatric outpatients. Anesthesiology. 1993;79:A1177.
36. Warner DL, Cabaret J, Velling D. Ketamine plus midazolam, a most effective paediatric oral premedicant. Paediatr Anaesth. 1995;5:293---5.
37. Dave NM. Premedication and Induction of Anaesthesia in paediatric patients. Indian J Anaesth. 2019;63:713---20.
38. Marshall J, Rodarte A, Blumer J, et al. Pediatric pharmacodynamics of midazolam oral syrup. Pediatric Pharmacology Research Unit Network. J Clin Pharmacol. 2000;40:578---89.
39. Ryhänen P, Kangas T, Rantakylä S. Premedication for outpatient adenoidectomy: comparison between ketamine and pethidine. Laryngoscope. 1980;90:494---500.
40. Cioaca˘ R, Canavea I. Oral transmucosal ketamine: an effective premedication in children. Paediatr Anaesth. 1996;6:361---5.
41. Horiuchi T, Kawaguchi M, Kurehara K, et al. Evaluation of relatively low dose of oral transmucosal ketamine premedication in children: a comparison with oral midazolam. Paediatr Anaesth. 2005;15:643---7.
42. Poonai N, Canton K, Ali S, et al. Intranasal ketamine for anesthetic premedication in children: a systematic review. Pain Manag. 2018;8:495---503.
43. Weksler N, Ovadia L, Muati G, et al. Nasal ketamine for paediatric premedication. Can J Anaesth. 1993;40:119---21.
44. Marhofer P, Freitag H, Höchtl A, et al. S(+)-ketamine for rectal premedication in children. Anesth Analg. 2001;92:62---5.
45. Wang X, Zhou ZJ, Zhang XF, et al. A comparison of two different doses of rectal ketamine added to 0.5 mg x kg(-1) midazolam and 0.02 mg x kg(-1) atropine in infants and young children. Anaesth Intensive Care. 2010;38:900---4.
46. Dinis-Oliveira RJ. Metabolism and metabolomics of ketamine: a toxicological approach. Forensic Sci Res. 2017;2:2---10.
47. Conway A, Rolley J, Sutherland JR. Midazolam for sedation before procedures. Cochrane Database Syst Rev. 2016;2016:CD009491.
48. Shi L, Lin L. The trim-and-fill method for publication bias: practical guidelines and recommendations based on a large database of meta-analyses. Medicine. 2019;98:e15987.
49. Guyatt GH, Oxman AD, Sultan S, et al. GRADE guidelines: 9. Rating up the quality of evidence. J Clin Epidemiol. 2011;64:1311---6.
50. Andrews J, Guyatt G, Oxman AD, et al. GRADE guidelines: 14. Going from evidence to recommendations: the significance and presentation of recommendations. J Clin Epidemiol. 2013;66:719---25.
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