Abstract
Pre-anaesthetic medication has the primary aim of making the whole process of anaesthesia smooth and agreeable. This prospective blind study was planned to compare the efficacy of three active drugs and a placebo as premedication in a paediatric population undergoing operation on a day care basis.
One hundred and fifty-nine patients between one and 12 years of age were assigned randomly to one of four groups who received either hydroxyzine 0.5 mg· kg-1(n - 43) promethazine 0.5mg · kg-1 (n 40) diazepam 0.1 mg · kg(n - 37) or placebo (n - 36) by mouth, 60 minutes before operation. Observations in the operating room included the emotional state of the patient on arrival, quality of induction and complications. In the recovery room time for emergence from anaesthesia, complications and requirements for analgesia were recorded. The parents were asked to return a questionnaire detailing psychological and physical complications during the three postoperative days.
There was no difference between the groups in any of the factors examined. From this study we conclude that children undergoing surgical operations and anaesthesia on a day care basis should not receive pharmacological premedication, not because of overwhelming risk from its use, but because of the absence of any benefit.
RéSUMé
Considé rant qu’une pré mé dication anesthé sique a comme but premier de rendre plus agré able et douce l’anesthé sie dans son ensemble, cette é tude prospective à double insu se veut une critique de trois types de pré mé dication comparativement a un placebo quant a leur valeur pour atteindre le but visé. L’é tude a aussi comme but d’inventorier les complications (pris dans son sens le plus large) autant physiques que psychologiques qui surviennent durant l’anesthé sie et dans le court et moyen terme du post-opé ratoire et d’en comparer l’incidence selon que les patients aient reçu un mé dicament actif ou le placebo. Pour ce, 159 patients agés de un à 12 ans furent sé lectionné s et distribué s au hazard entre quatre groupes thé rapeutiques (hydroxyzine 0.5 mg- kg-1, promethazine 0.5 mg· kg-1, diazepan 0.1 mg · kg-1 et un placebo) qui reçurent tous la pré mé dication per os sous forme d’é lixir environ 60 minutes avant l’induction de l’anesthé sie. De ces 159 patients, 137 dossiers sont complets, les parents ayant retourné leur partie de l’é valuation consernant l’é volution à la maison. Cette etude nous a permis d’obtenir les ré sultats suivants:
- il n’existe aucune diffé rence statistiquement significative entre les quatre groupes thé rapeutiques et la qualité de l’induction anaesthé sique même si l’hydroxyzine donnait des patients plus calmes que le placebo a l’arrivée en salle d’opé ration.
- l’incidence des complications par et post opé ratoire et leur sé vé rité sont les même dans les quatre groupes et aucun n’a pré senté d’avantage de ré actions psychologiques que l’autre a la maison (insomnie, é nuré sie, perte de propreté diurne, agressivité accrue, identification à l’agresseur, dé pression psycho-motrice, besoins affectifs accrus et crainte d’être puni). De plus le groupe de patient dont l’induction anesthé sique a é té la plus orageuse n’a pas montré d’incidence accrue de ré actions psychologiques post-operatoire.
- les dé lais observé s pour les diffé rents stades d’é veil sont les mêmes dans les quatre groupes thé rapeutiques, ainsi que dans le groupe à induction orageuse vs celui avec une induction plus douce.
- finalement nous avons observé un taux de satisfaction des anesthé sistes face a la pré mé dication recue d’environ 80 pour cent dans les quatre groupes et un taux de satisfaction de 90 pour cent chez les parents face a l’hospitalisation dans son ensemble. Nous concluons de cette é tude que la population pé diatrique devant subie une anesthé sie et une chirurgie en externe ne devrait pas reçevoir de pré mé dication pharmacologique (ormis de l’atropine IV a l’induction); non pas à cause de risques accrus avec l’utilisation de prémédication, mais à cause de l’absence de bé né fice encouru dans cette étude.
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Presented at the Annual Meeting, Canadian Anaesthetists’ Society, Toronto, Ontario. June 23, 1980.
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Desjardins, R., Ansara, S. & Charest, J. Pre-anaesthetic medication in paediatric day-care surgery. Canad. Anaesth. Soc. J. 28, 141–148 (1981). https://doi.org/10.1007/BF03007258
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DOI: https://doi.org/10.1007/BF03007258