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Comparing two treatments for shivering after cesarean delivery for labor dystocia under epidural anesthesia.
It is a double blinded randomized control trial.
Study population: parturients undergoing a cesarean delivery for labor dystocia under epidural anesthesia experiencing shivering grade III or IV on the standardized shivering scale of Crossley and Mahajan
Experimental group: dexmedetomidine 0.35 mcg/kg IV in 2 minutes
Control group: meperidine 0.35 mg/kg IV in 2 minutes
Primary outcome : Time to stop level III and IV shivering on the Crossley and Mahajan standardized shivering scale after the administration of the study drug
Secondary outcome: Response rate, incidence of nausea, vomiting, hypotension, bradycardia, maternal satisfaction and a cost-benefit analysis.
The hypothesis is that dexmedetomidine will act faster, will have a superior response rate with less adverse effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dexmedetomidine | Experimental | Unique dose of dexmedetomidine injection:
|
|
| meperidine | Active Comparator | Unique dose of meperidine injection:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine Injection | Drug | 0.35 mcg/kg intravenous in 2 minutes if shivering 5 minutes after delivery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Stop time | Time to stop class III or IV shivering on the Crossley and Mahajan standardized shivering scale after the administration of the study drug (meperidine versus dexmedetomidine) | 15 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| incidence of adverse effects | sedation, nausea, vomiting, hypotension and bradycardia | 24 hours |
| maternal satisfaction | satisfaction (yes or no) regarding experience with study drug |
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Inclusion Criteria:
Exclusion Criteria:
Parturient, after cesarean delivery
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| Name | Affiliation | Role |
|---|---|---|
| Anne Lavoie, MD, FRCPC | Centre hospitalier de l'Université de Montréal (CHUM) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier de l'Université de Montréal | Montreal | Quebec | H2X 3J4 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18433676 | Background | Crowley LJ, Buggy DJ. Shivering and neuraxial anesthesia. Reg Anesth Pain Med. 2008 May-Jun;33(3):241-52. doi: 10.1016/j.rapm.2007.11.006. | |
| 11818783 | Background | De Witte J, Sessler DI. Perioperative shivering: physiology and pharmacology. Anesthesiology. 2002 Feb;96(2):467-84. doi: 10.1097/00000542-200202000-00036. No abstract available. |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D008614 | Meperidine |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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Comparing two groups: experimental (dexmedetomidine) versus control (meperidine)
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Double-blinded randomized study: meperidine and dexmedetomidine will be prepared at the hospital pharmacy in a 10 mL seringue with equivalent dilution in order to gave mL/kg.
| Meperidine Injection | Drug | 0.35 mg/kg intravenous in 2 minutes if shivering 5 minutes after delivery |
|
|
| at 24 hours |
| response rate | percentage of patient responding when the drug is given | 15 minutes |
| cost benefice analysis | comparing cost of the drug | 24 hours |
| 11812718 | Background | Kranke P, Eberhart LH, Roewer N, Tramer MR. Pharmacological treatment of postoperative shivering: a quantitative systematic review of randomized controlled trials. Anesth Analg. 2002 Feb;94(2):453-60, table of contents. doi: 10.1097/00000539-200202000-00043. |
| 27228512 | Background | Abdel-Ghaffar HS, Mohamed SA, Fares KM, Osman MA. Safety and Efficacy of Dexmedetomidine in Treating Post Spinal Anesthesia Shivering: A Randomized Clinically Controlled Dose-Finding Trial. Pain Physician. 2016 May;19(4):243-53. |
| 11682416 | Background | Tsai YC, Chu KS. A comparison of tramadol, amitriptyline, and meperidine for postepidural anesthetic shivering in parturients. Anesth Analg. 2001 Nov;93(5):1288-92. doi: 10.1097/00000539-200111000-00052. |
| 25024466 | Background | Mittal G, Gupta K, Katyal S, Kaushal S. Randomised double-blind comparative study of dexmedetomidine and tramadol for post-spinal anaesthesia shivering. Indian J Anaesth. 2014 May;58(3):257-62. doi: 10.4103/0019-5049.135031. |
| 9690596 | Background | Saito T, Sessler DI, Fujita K, Ooi Y, Jeffrey R. Thermoregulatory effects of spinal and epidural anesthesia during cesarean delivery. Reg Anesth Pain Med. 1998 Jul-Aug;23(4):418-23. doi: 10.1016/s1098-7339(98)90017-7. |
| 8147511 | Background | Crossley AW, Mahajan RP. The intensity of postoperative shivering is unrelated to axillary temperature. Anaesthesia. 1994 Mar;49(3):205-7. doi: 10.1111/j.1365-2044.1994.tb03422.x. |
| D007540 |
| Isonipecotic Acids |
| D000147 | Acids, Heterocyclic |
| D010880 | Piperidines |