The Effects of Single-dose Rectal Midazolam Application on Post-operative Recovery
28 avril 2014 mis à jour par: SEDAT SAYLAN, Karadeniz Technical University
The Effects of Single-dose Rectal Midazolam Application on Post-operative Recovery, Sedation, and Analgesia in Children Given Caudal Anesthesia Plus Bupivacaine
This study aimed to compare the efficiency of rectal midazolam addition after applying bupivacaine and caudal anesthesia on postoperative analgesia time, the need for additional analgesics, postoperative recovery, sedation, and to find out its adverse effects in children having lower abdominal surgery.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
Summary Background: This study aimed to compare the efficiency of rectal midazolam addition after applying bupivacaine and caudal anesthesia on postoperative analgesia time, the need for additional analgesics, postoperative recovery, sedation, and to find out its adverse effects in children having lower abdominal surgery.
Methods: 40 children between 2 and 10 years of American Society of Anesthesiologist (ASA) I-II stages were randomized and applied caudal anesthesia under general anesthesia. Patients were applied caudal block in addition with saline and 1milliliter/kilograms (mL/kg) bupivacaine 0.25%. In the postoperative period, Group C (n=20) was given 5 milliliter (mL) saline and Group M (n=20) was given 0.30 mg/kg rectal midazolam diluted with 5mL saline. Sedation scale and postoperative pain scale (CHIPPS) of the patients were evaluated. The patients were observed for their analgesic need, first analgesic time, and adverse effects for 24 hours.
Type d'étude
Interventionnel
Inscription (Réel)
40
Phase
- Phase 4
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
-
Trabzon, Turquie, 61080
- Karadeniz Technical University Faculty of Medicine
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
2 ans à 10 ans (Enfant)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- children having lower abdominal surgery
Exclusion Criteria:
- Children with significant respiratory system, circulatory system, liver, and kidney function disorder, history of allergy to the drugs to be studied, those who received analgesic medication before the operation, and those for whom caudal anesthesia is contraindicated
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: Midazolam
1 mL/kg bupivacaine 0.25%.
|
40 children between 2 and 10 years of ASA I-II were randomized and they received caudal anesthesia under general anesthesia.
Patients underwent the application of caudal block in addition with saline and 1 mL/kg bupivacaine 0.25%.
In the postoperative period, Group C (n=20) was given 5mL saline and Group M (n=20) was given 0.30 mg/kg rectal midazolam diluted with 5mL saline.
Sedation scale and postoperative pain scale (CHIPPS) of the patients were evaluated.
The patients were observed for their analgesic need, first analgesic time, and adverse effects for 24 hours.
Autres noms:
|
|
Comparateur placebo: saline
5mL rectal saline
|
40 children between 2 and 10 years of ASA I-II were randomized and they received caudal anesthesia under general anesthesia.
Patients underwent the application of caudal block in addition with saline and 1 mL/kg bupivacaine 0.25%.
In the postoperative period, Group C (n=20) was given 5mL saline and Group M (n=20) was given 0.30 mg/kg rectal midazolam diluted with 5mL saline.
Sedation scale and postoperative pain scale (CHIPPS) of the patients were evaluated.
The patients were observed for their analgesic need, first analgesic time, and adverse effects for 24 hours.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Sedation scale and postoperative pain scale (CHIPPS)
Délai: 24 hours
|
Sedation scale and postoperative pain scale (CHIPPS) of the patients were evaluated.
The patients were observed for their analgesic need, first analgesic time, and adverse effects for 24 hours.
|
24 hours
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: SEDAT SAYLAN, Med. doctor, KANUNI EDUCATION AND RESEARCH HOSPITAL, TRABZON ,TURKEY
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. doi: 10.1016/0022-3956(75)90026-6. No abstract available.
- Lee HM, Sanders GM. Caudal ropivacaine and ketamine for postoperative analgesia in children. Anaesthesia. 2000 Aug;55(8):806-10. doi: 10.1046/j.1365-2044.2000.01330-2.x.
- Kanegaye JT, Favela JL, Acosta M, Bank DE. High-dose rectal midazolam for pediatric procedures: a randomized trial of sedative efficacy and agitation. Pediatr Emerg Care. 2003 Oct;19(5):329-36. doi: 10.1097/01.pec.0000092578.40174.85.
- Silvani P, Camporesi A, Agostino MR, Salvo I. Caudal anesthesia in pediatrics: an update. Minerva Anestesiol. 2006 Jun;72(6):453-9.
- Kehlet H. The stress response to surgery: release mechanisms and the modifying effect of pain relief. Acta Chir Scand Suppl. 1989;550:22-8.
- Shavit I, Keidan I, Augarten A. The practice of pediatric procedural sedation and analgesia in the emergency department. Eur J Emerg Med. 2006 Oct;13(5):270-5. doi: 10.1097/00063110-200610000-00005.
- Mahajan R, Batra YK, Grover VK, Kajal J. A comparative study of caudal bupivacaine and midazolam-bupivacaine mixture for post-operative analgesia in children undergoing genitourinary surgery. Int J Clin Pharmacol Ther. 2001 Mar;39(3):116-20. doi: 10.5414/cpp39116.
- Breschan C, Schalk HV, Schaumberger F, Likar R. Experience with caudal blocks in children over a period of 3.5 years. Acta Anaesthesiol Scand Suppl. 1996;109:174-6. No abstract available.
- Sumpelmann R, Munte S. Postoperative analgesia in infants and children. Curr Opin Anaesthesiol. 2003 Jun;16(3):309-13. doi: 10.1097/00001503-200306000-00011.
- Clausen TG, Wolff J, Hansen PB, Larsen F, Rasmussen SN, Dixon JS, Crevoisier C. Pharmacokinetics of midazolam and alpha-hydroxy-midazolam following rectal and intravenous administration. Br J Clin Pharmacol. 1988 Apr;25(4):457-63. doi: 10.1111/j.1365-2125.1988.tb03330.x.
- McGrath PJ, McAlpine L. Psychologic perspectives on pediatric pain. J Pediatr. 1993 May;122(5 Pt 2):S2-8. doi: 10.1016/s0022-3476(11)80002-8.
- Tyler DC, Tu A, Douthit J, Chapman RC. Toward validation of pain measurement tools for children: a pilot study. Pain. 1993 Mar;52(3):301-309. doi: 10.1016/0304-3959(93)90163-J.
- Roy RC. Choosing general versus regional anesthesia for the elderly. Anesthesiol Clin North Am. 2000 Mar;18(1):91-104, vii. doi: 10.1016/s0889-8537(05)70151-6.
- Somri M, Gaitini LA, Vaida SJ, Yanovski B, Sabo E, Levy N, Greenberg A, Liscinsky S, Zinder O. Effect of ilioinguinal nerve block on the catecholamine plasma levels in orchidopexy: comparison with caudal epidural block. Paediatr Anaesth. 2002 Nov;12(9):791-7. doi: 10.1046/j.1460-9592.2002.00916.x.
- Solak M, Ulusoy H, Sarihan H. Effects of caudal block on cortisol and prolactin responses to postoperative pain in children. Eur J Pediatr Surg. 2000 Aug;10(4):219-23. doi: 10.1055/s-2008-1072362.
- Golianu B, Krane EJ, Galloway KS, Yaster M. Pediatric acute pain management. Pediatr Clin North Am. 2000 Jun;47(3):559-87. doi: 10.1016/s0031-3955(05)70226-1.
- Martinez-Telleria A, Cano Serrano ME, Martinez-Telleria MJ, Castejon Casado J. [Analysis of regional anesthetic efficacy in pediatric postop pain]. Cir Pediatr. 1997 Jan;10(1):18-20. Spanish.
- Da Conceicao MJ, Coelho L. Caudal anaesthesia with 0.375% ropivacaine or 0.375% bupivacaine in paediatric patients. Br J Anaesth. 1998 Apr;80(4):507-8. doi: 10.1093/bja/80.4.507.
- Gann DS, Lilly MP. The neuroendocrine response to multiple trauma. World J Surg. 1983 Jan;7(1):101-18. doi: 10.1007/BF01655918. No abstract available.
- Reier CE, George JM, Kilman JW. Cortisol and growth hormone response to surgical stress during morphine anesthesia. Anesth Analg. 1973 Nov-Dec;52(6):1003-10. No abstract available.
- Saylan S, Eroglu A, Dohman D. The effects of single-dose rectal midazolam application on postoperative recovery, sedation, and analgesia in children given caudal anesthesia plus bupivacaine. Biomed Res Int. 2014;2014:127548. doi: 10.1155/2014/127548. Epub 2014 May 5.
Liens utiles
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 juin 2005
Achèvement primaire (Réel)
1 juin 2006
Achèvement de l'étude (Réel)
1 juin 2006
Dates d'inscription aux études
Première soumission
18 avril 2014
Première soumission répondant aux critères de contrôle qualité
28 avril 2014
Première publication (Estimation)
30 avril 2014
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
30 avril 2014
Dernière mise à jour soumise répondant aux critères de contrôle qualité
28 avril 2014
Dernière vérification
1 avril 2014
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- B.30.2.KTU.0.01.00.01/372
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .