Does the Preoperative Midazolam Dose Affect Postoperative Pain?
NCT ID: NCT03534895
Last Updated: 2018-05-23
Study Results
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Basic Information
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UNKNOWN
PHASE4
168 participants
INTERVENTIONAL
2019-05-31
2020-08-31
Brief Summary
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The investigators hypothesize that patients being administered higher midazolam doses will refer more pain.
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Detailed Description
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The investigators will use multiple regression models to explore the interaction of midazolam dose with preoperative anxiety, gender and chronic benzodiazepine use, as they hypothesize there might be a differential effect of midazolam on postoperative pain amongst these subgroups.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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PC1
5mL normal saline intravenous, single-administration, as pre-medication
Normal saline
intravenous
Spinal anesthesia
8mg of heavy bupivacaine 0.5% injected in the subarachnoid space, during lateral decubitus
Surgery
Open inguinal hernia repair, varicose vein stripping, knee arthroscopy or hallux valgus surgery
Postoperative analgesia
IV acetaminophen 1g + IV ketorolac 30mg
Rescue analgesia
Tramadol 2mg/Kg IV in 100mL of normal saline, if pain NRS\>3.
Wound infiltration
Wound infiltration with 10mL of ropivacaine 0.75%, in open inguinal hernia repair
Analgesia at home
Oral acetaminophen 1g 6/6h + ibuprofen 400mg 8/8h (+ rescue analgesia with tramadol 50mg 6/6h)
PC2
midazolam 0.02mg/Kg in 5mL normal saline, intravenous, single-administration, as pre-medication
Midazolam Injectable Solution
intravenous
Normal saline
intravenous
Spinal anesthesia
8mg of heavy bupivacaine 0.5% injected in the subarachnoid space, during lateral decubitus
Surgery
Open inguinal hernia repair, varicose vein stripping, knee arthroscopy or hallux valgus surgery
Postoperative analgesia
IV acetaminophen 1g + IV ketorolac 30mg
Rescue analgesia
Tramadol 2mg/Kg IV in 100mL of normal saline, if pain NRS\>3.
Wound infiltration
Wound infiltration with 10mL of ropivacaine 0.75%, in open inguinal hernia repair
Analgesia at home
Oral acetaminophen 1g 6/6h + ibuprofen 400mg 8/8h (+ rescue analgesia with tramadol 50mg 6/6h)
PC3
midazolam 0.06mg/Kg in 5mL normal saline, intravenous, single-administration, as pre-medication
Midazolam Injectable Solution
intravenous
Normal saline
intravenous
Spinal anesthesia
8mg of heavy bupivacaine 0.5% injected in the subarachnoid space, during lateral decubitus
Surgery
Open inguinal hernia repair, varicose vein stripping, knee arthroscopy or hallux valgus surgery
Postoperative analgesia
IV acetaminophen 1g + IV ketorolac 30mg
Rescue analgesia
Tramadol 2mg/Kg IV in 100mL of normal saline, if pain NRS\>3.
Wound infiltration
Wound infiltration with 10mL of ropivacaine 0.75%, in open inguinal hernia repair
Analgesia at home
Oral acetaminophen 1g 6/6h + ibuprofen 400mg 8/8h (+ rescue analgesia with tramadol 50mg 6/6h)
Interventions
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Midazolam Injectable Solution
intravenous
Normal saline
intravenous
Spinal anesthesia
8mg of heavy bupivacaine 0.5% injected in the subarachnoid space, during lateral decubitus
Surgery
Open inguinal hernia repair, varicose vein stripping, knee arthroscopy or hallux valgus surgery
Postoperative analgesia
IV acetaminophen 1g + IV ketorolac 30mg
Rescue analgesia
Tramadol 2mg/Kg IV in 100mL of normal saline, if pain NRS\>3.
Wound infiltration
Wound infiltration with 10mL of ropivacaine 0.75%, in open inguinal hernia repair
Analgesia at home
Oral acetaminophen 1g 6/6h + ibuprofen 400mg 8/8h (+ rescue analgesia with tramadol 50mg 6/6h)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* alcoholism
* illiteracy or poor understanding of Portuguese language
* history of chronic pain under opioids
* recurrent surgery
* contraindication for midazolam or deep sedation
* contraindication for spinal anesthesia
18 Years
ALL
No
Sponsors
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Centro Hospitalar de Entre o Douro e Vouga
OTHER
Centro Hospitalar de Vila Nova de Gaia/Espinho
OTHER
Universidade do Porto
OTHER
Responsible Party
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Caroline Dahlem
Principal Investigator
Locations
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Centro Hospitalar Entre Douro e Vouga, EPE
Santa Maria da Feira, , Portugal
Centro Hospitalar Vila Nova de Gaia / Espinho, EPE
Vila Nova de Gaia, , Portugal
Countries
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Central Contacts
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Facility Contacts
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Caroline Dahlem, MD
Role: primary
Carmen Oliveira, MD
Role: primary
References
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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.
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.
Frolich MA, Zhang K, Ness TJ. Effect of sedation on pain perception. Anesthesiology. 2013 Mar;118(3):611-21. doi: 10.1097/ALN.0b013e318281592d.
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.
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.
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.
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.
Other Identifiers
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Midazolam RCT
Identifier Type: -
Identifier Source: org_study_id
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