To evaluate the effectiveness of adrenaline infiltration, topical adrenaline, systemic tranexamic acid, fibrin tissue sealants and alginate-based topical coagulants at reducing blood loss and post-operative bleeding in primary cleft palate repair.
Design
Systematic review according to PRISMA-P guidelines, using Covidence systematic review software to facilitate 3-stage screening and data extraction by two reviewers.
Setting
Academic cleft surgery center.
Interventions
Any peri-operative intervention to reduce intra-operative and post-operative bleeding.
Main Outcome Measures
Estimated blood loss, rate of post-operative bleeding, rate of return to theatre for haemostasis.
Results
Sixteen relevant studies were identified, with a total of 1469 study participants. Nine studies examined efficacy of infiltrating vasoconstrictors and all concluded that 1:100,000–1:400,000 adrenaline infiltration reduced intra-operative blood loss, to the range of 12-60 ml. Secondary bleeding and re-operation for haemostasis were uncommon. Tranexamic acid was studied in five randomised controlled trials, two of which demonstrated a significant reduction in blood loss compared to a control group. Use of fibrin and gelatin sponge products was examined in 3 studies, all of which reported no or minimal bleeding, but did not have quantifiable outcome measures.
Conclusions
Infiltration with vasoconstricting agents, administration of systemic tranexamic acid and application of fibrin sealants have a well-studied and favorable safety profile in pediatric cases, and likely contribute to the relatively low incidence of post-operative bleeding and intra-operative blood loss in primary cleft palate repair.
PaineKMPaligaJTTahiriY, et al.An assessment of 30-day complications in primary cleft palate repair: A review of the 2012 ACS NSQIP pediatric. Cleft Palate Craniofac J. May 2016;53(3):357‐362. doi:10.1597/14-193
2.
Rossell-PerryPSchneiderWJGavino-GutierrezAM. A comparative study to evaluate a simple method for the management of postoperative bleeding following palatoplasty. Arch Plast Surg. May 2013;40(3):263‐266. doi:10.5999/aps.2013.40.3.263
3.
SchönmeyrBWendbyLCampbellA. Surgical complications in 1408 primary cleft palate repairs operated at a single center in guwahati, assam, India. Cleft Palate Craniofac J. May 2016;53(3):278‐282. doi:10.1597/14-206
4.
MetsEJChouairiFTorabiSJAlperovichM. Predictors of adverse events following cleft palate repair. J Craniofac Surg. Jul 2019;30(5):1414‐1418. doi:10.1097/scs.0000000000005542
5.
KimBJChoiTHKimS. Prospective study on the intraoperative blood loss in patients with cleft palate undergoing Furlow's double opposing Z-palatoplasty. Cleft Palate Craniofac J. Aug 2018;55(7):954‐958. doi:10.1597/15-278
6.
BallestasSATurnerTCKamalakarA, et al.Improving hard palate wound healing using immune modulatory autotherapies. Acta Biomater. Jun 2019;91:209-219. doi:10.1016/j.actbio.2019.04.052
7.
RintalaA. Blood loss in cleft palate surgery. Article. Acta Chir Scand.1965;129:288‐291.
8.
KinsellaCRJrCastilloNNaranS, et al.Intraoperative high-dose epinephrine infiltration in cleft palate repair. J Craniofac Surg. Jan 2014;25(1):140‐142. doi:10.1097/SCS.0000000000000376
9.
AryaVKMuthukumarMMathewPJSharmaRK. Comparison of different concentrations of Adrenaline with or without lignocaine for surgical field infiltration during cleft lip and cleft palate surgery in children. Journal: Conference Abstract. Anaesthesia and Intensive Care. 2010;38(6):1109‐1110.
10.
GunnamPRDurgaPGurajalaIKaluvalaPRVeerabathulaPRamachandranG. Comparison of hemodynamic response to Adrenaline infiltration in children undergoing cleft palate repair during general anesthesia with sevoflurane and isoflurane. Journal: Article. Journal of Anaesthesiology, Clinical Pharmacology. 2016;32(1):12‐17. doi:10.4103/0970-9185.175650
11.
MuthukumarMAryaVKMathewPJSharmaRK. Comparison of haemodynamic responses following different concentrations of Adrenaline with and without lignocaine for surgical field infiltration during cleft lip and cleft palate surgery in children. Anaesth Intensive Care. Jan 2012;40(1):114‐119. doi:10.1177/0310057X1204000112
12.
DurgaPRaavulaPGurajalaI, et al.Evaluation of the efficacy of tranexamic acid on the surgical field in primary cleft palate surgery on children-A prospective, randomized clinical study. Cleft Palate Craniofac J. Sep 2015;52(5):e183‐e187. doi:10.1597/14-263
13.
GoobieSMFaraoniD. Tranexamic acid and perioperative bleeding in children: What do we still need to know?Curr Opin Anaesthesiol. Jun 2019;32(3):343‐352. doi:10.1097/ACO.0000000000000728
14.
JacksonMR. Fibrin sealants in surgical practice: An overview. Am J Surg. Aug 2001;182(2 Suppl):1S‐7S. doi:10.1016/s0002-9610(01)00770-x
15.
LiJGeretyPAJohnstonJTaylorJA. Gelfoam interposition minimizes risk of Fistula and postoperative bleeding in modified-furlow palatoplasty. J Craniofac Surg. Nov 2017;28(8):1993‐1996. doi:10.1097/scs.0000000000003616
16.
WhitmanDHBerryRLGreenDM. Platelet gel: An autologous alternative to fibrin glue with applications in oral and maxillofacial surgery. J Oral Maxillofac Surg. Nov 1997;55(11):1294‐1299. doi:10.1016/s0278-2391(97)90187-7
17.
PageMJMcKenzieJEBossuytPM, et al.The PRISMA 2020 statement: An updated guideline for reporting systematic reviews. Int J Surg. Apr. 2021;88:105906. doi:10.1016/j.ijsu.2021.105906
HigginsJPAltmanDGGotzschePC, et al.The Cochrane Collaboration's tool for assessing risk of bias in randomised trials. Br Med J.Oct 18 2011;343:d5928. doi:10.1136/bmj.d5928
20.
SterneJAHernánMAReevesBC, et al.ROBINS-I: A tool for assessing risk of bias in non-randomised studies of interventions. BMJ (Clinical Research ed). Oct 12 2016;355:i4919. doi:10.1136/bmj.i4919
21.
MunnZBarkerTHMoolaS, et al.Methodological quality of case series studies: An introduction to the JBI critical appraisal tool. JBI Evid Synth. Oct 2020;18(10):2127‐2133. doi:10.11124/JBISRIR-D-19-00099
IkemuraKShirahataANakamuraT. Repair of a cleft palate in a child with hemophilia A. Article. Journal of UOEH. 1983;5(2):277‐282. doi:10.7888/juoeh.5.277
24.
WuRWilsonATraviesoRSteinbacherDM. Fibrin tissue sealant as an adjunct to cleft palate repair. J Craniofac Surg. Jul 2017;28(5):1164‐1166. doi:10.1097/SCS.0000000000003653
25.
SahaSSKumarVKhazanchiRK, et al.Ambulatory cleft lip and palate surgery by tumescent technique. Plast Reconstr Surg. Apr. 2005;115(4):1210‐1212. doi:10.1097/01.prs.0000157542.75526.85
26.
KhavidakiGDYaghoubiSNaderiMMalekF. The Effect of Preoperative Intravenous Tranexamic Acid on the Amount of Bleeding in Patients Undergoing Cleft Palate Reconstruction Surgery. Article. Iran J Pediatr.2022;32(5). doi:10.5812/ijp-118170
27.
ArantesGCPereiraRMRde MeloDBAlonsoNDuarteM. Effectiveness of tranexamic acid for reducing intraoperative bleeding in palatoplasties: A randomized clinical trial. Journal of Cranio-Maxillo-Facial Surgery: Official Publication of the European Association for Cranio-Maxillo-Facial Surgery. May 2017;45(5):642‐648. doi:10.1016/j.jcms.2016.12.021
28.
De MeyAGovaertsMJMCapouetVGregoireJPLejourM. Comparison of the vasoconstrictive effect of adrenalin and POR 8 in cleft lip and palate surgery. Eur J Plast Surg.1987;10(1):21‐23.
29.
NishatMIqbalSAhmedAYounasSDeokahLARashidZ. Clinical study of evaluation of the effect of tranexamic acid in primary cleft palate surgery in children. Article. Pakistan Journal of Medical and Health Sciences. 2021;15(10):2708‐2709. doi:10.53350/pjmhs2115102708
30.
ShafaAShetabiHAdineh-MehrLBahramiK. Selection of the optimal dosage of tranexamic acid to reduce blood loss during pediatric cleft palate surgery. Tzu Chi Med J. Apr-Jun 2021;33(2):181‐187. doi:10.4103/tcmj.tcmj_111_20
31.
KantarRSCammarataMJRifkinWJPlanaNMDiaz-SisoJRFloresRL. Outpatient versus inpatient primary cleft lip and palate surgery: Analysis of early complications. Plast Reconstr Surg. May 2018;141(5):697e‐706e. doi:10.1097/PRS.0000000000004293
32.
ParkEDeshpandeGSchonmeyrBRestrepoCCampbellA. Improved early cleft lip and palate complications at a surgery specialty center in the developing world. Cleft Palate Craniofac J. Sep 2018;55(8):1145‐1152. doi:10.1177/1055665618762881
33.
SwanMCThorburnGSommerladBC, et al.Intraoperative high-dose epinephrine infiltration in cleft palate repair. Letter. J Craniofac Surg.2014;25(5):1934. doi:10.1097/SCS.0000000000001008
34.
ElhakimMOmarNSel-KaderAAZowelT. Cardiac dysrhythmias during nasal surgery–a comparison with lignocaine-Adrenaline and prilocaine-octapressin during halothane anaesthesia. Anaesthesiol Reanim. 1990;15(4):199‐203.
35.
VeitSPoethkoCHeidelmeyerCFBrucknerJB. [Ornipressin (POR 8)–effect on coronary blood circulation and the peripheral circulation. An animal experimental study]. Anaesthesist. Sep 1993;42(9):597‐604. Ornipressin (POR 8)–Wirkung auf die Koronardurchblutung und die periphere Zirkulation. Eine tierexperimentelle Studie.
36.
RintalaATammistoT. Effect of octapressin -epinephrine on operative bleeding; A comparative study. Article. Ann Chir Gynaecol Fenn.1965;54:52‐56.
37.
RintalaA. Haemostatic effect of Ornithine8-vasopressin on operative bleeding :An experimental clinical study. Article. Acta Anaesthesiol Scand.1968;12(2):89‐94. doi:10.1111/j.1399-6576.1968.tb00414.x
38.
MillayDJLarrabeeWFJrCarpenterRL. Vasoconstrictors in facial plastic surgery. Arch Otolaryngol Head Neck Surg. Feb 1991;117(2):160‐163. doi:10.1001/archotol.1991.01870140048004
39.
ManoukianMACTancrediDJNishijimaDK. Effect of age on the efficacy of tranexamic acid: An analysis of heterogeneity of treatment effect within the CRASH-2 dataset. Am J Emerg Med. Mar 2022;53:37‐40. doi:10.1016/j.ajem.2021.12.033
40.
Zapata-CopeteJAGomez-OspinaJCGarcia-PerdomoHACaycedoDJ. Role of tranexamic acid in craniosynostosis surgery: Systematic review and meta-analysis. J Plast Reconstr Aesthet Surg. Apr 2022;75(4):1389‐1398. doi:10.1016/j.bjps.2021.11.064
41.
FellMDaviesADaviesA, et al.Current Surgical Practice for Children Born with a Cleft lip and/or Palate in the United Kingdom. Cleft Palate Craniofacjun 2023;60(6):679-688. doi: 10.1177/10556656221078151
42.
GrabarCFligorJKanackMWalshJKimJVyasR. A Survey on Enhanced Recovery After Surgery (ERAS) Elements in Cleft Palate Repair. Cleft Palate Craniofac J. May 26 2022;10556656221103756. doi:10.1177/10556656221103756
43.
YangASRichardBMWillsAKMahmoudOSandyJRNessAR. Closer to the truth on national Fistula prevalence after unilateral complete cleft lip and palate repair? The cleft care UK study. Cleft Palate Craniofac J. Jan 2020;57(1):5‐13. doi:10.1177/1055665619858871
44.
CawthornTRToddARHardcastleNSpencerAOHarropARFraulinFOG. Optimizing outcomes after cleft palate repair: Design and implementation of a perioperative clinical care pathway. Cleft Palate Craniofac J. May 2022;59(5):561‐567. doi:10.1177/10556656211017409
45.
HushSEChenJTBradyCM, et al.Implementation of a modified enhanced recovery protocol in cleft palate repairs. J Craniofac Surg. Oct 2019;30(7):2154‐2158. doi:10.1097/scs.0000000000005718
46.
AsadourianPALu WangMDemetresMRImahiyeroboTAOtterburnDM. Closing the Gap: A Systematic Review and Meta-Analysis of Enhanced Recovery After Surgery Protocols in Primary Cleft Palate Repair. Cleft Palate Craniofac J. May 18 2022;10556656221096631. doi:10.1177/10556656221096631
47.
BashaSSrinathNKumarNBalajiR. Role of fibrin glue in palatoplasty to prevent formation of oro-nasal fistula – an in vivo study. Article. Asian Journal of Oral and Maxillofacial Surgery. 2011;23(4):177‐180. doi:10.1016/j.ajoms.2011.05.002
48.
WitmerDSolomitoMJKumarMShearierEDavisS. Efficacy and safety of locally injected tranexamic acid in hip fracture patients: A retrospective review. J Orthop Trauma. Mar 1 2022;36(3):147‐151. doi:10.1097/bot.0000000000002241
