drugset / Trial / NCT03534895
Does the Preoperative Midazolam Dose Affect Postoperative Pain?
Phase 4
Unknown
168 enrolled
University of Porto
Centro Hospitalar de Entre o Douro e Vouga · collabCentro Hospitalar de Vila Nova de Gaia/Espinho · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
To investigate whether midazolam has any effect on postoperative pain in outpatient surgery, the investigators will assess the impact of different midazolam doses on pain scores 24h, 7 days and 3 months after ambulatory surgery. The investigators hypothesize that patients being administered higher midazolam doses will refer more pain.
Timeline
- Start
- 2019-05
- Primary completion
- 2020-05
- Completion
- 2020-08
Publications
- Background Mantegazza P, Parenti M, Tammiso R, Vita P, Zambotti F, Zonta N. Modification of the antinociceptive effect of morphine by centrally administered diazepam and midazolam. Br J Pharmacol. 1982 Apr;75(4):569-72. doi: 10.1111/j.1476-5381.1982.tb09175.x.
- Background Tatsuo MA, Salgado JV, Yokoro CM, Duarte ID, Francischi JN. Midazolam-induced hyperalgesia in rats: modulation via GABA(A) receptors at supraspinal level. Eur J Pharmacol. 1999 Apr 1;370(1):9-15. doi: 10.1016/s0014-2999(99)00096-5.
- Background Frolich MA, Zhang K, Ness TJ. Effect of sedation on pain perception. Anesthesiology. 2013 Mar;118(3):611-21. doi: 10.1097/ALN.0b013e318281592d.
- Background Kain ZN, Sevarino F, Pincus S, Alexander GM, Wang SM, Ayoub C, Kosarussavadi B. Attenuation of the preoperative stress response with midazolam: effects on postoperative outcomes. Anesthesiology. 2000 Jul;93(1):141-7. doi: 10.1097/00000542-200007000-00024.
- Background Day MA, Rich MA, Thorn BE, Berbaum ML, Mangieri EA. A placebo-controlled trial of midazolam as an adjunct to morphine patient-controlled analgesia after spinal surgery. J Clin Anesth. 2014 Jun;26(4):300-8. doi: 10.1016/j.jclinane.2013.12.011. Epub 2014 Jun 2.
- Background Okulicz-Kozaryn I, Kaminska E, Luczak J, Szczawinska K, Kotlinska-Lemieszek A, Baczyk E, Mikolajczak P. The effects of midazolam and morphine on analgesic and sedative activity of ketamine in rats. J Basic Clin Physiol Pharmacol. 2000;11(2):109-25. doi: 10.1515/jbcpp.2000.11.2.109.
- Background Hasani A, Maloku H, Sallahu F, Gashi V, Ozgen SU. Preemptive analgesia with midazolam and diclofenac for hernia repair pain. Hernia. 2011 Jun;15(3):267-72. doi: 10.1007/s10029-010-0772-y. Epub 2010 Dec 28.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Midazolam | Small molecule | 0.02 mg/kg | Intravenous |
| Subject | Midazolam | Small molecule | 0.06 mg/kg | Intravenous |
| Background | Acetaminophen | Small molecule | 1 g | Intravenous |
| Background | Ketorolac | Other / unclassified | 30 mg | Intravenous |
| Background | Ropivacaine | Other / unclassified | 0.75 % | Other |
| Background | Ropivacaine | Other / unclassified | 10 ml | Other |
| Background | Tramadol | Other / unclassified | 2 mg/kg | Intravenous |
| Background | Tramadol | Other / unclassified | 50 mg | Intravenous |