Does Midazolam Affect Postoperative Pain?

NCT03499730 | Completed

• 1 other identifier: Midazolam OBS
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 4

Brief 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 open inguinal hernia repair. The investigators hypothesize that patients being administered higher midazolam doses will refer more pain.

Conditions

Pain, Postoperative

Keywords

Midazolam; Inguinal hernia

Outcome Measures

Primary Outcomes (1)

• Postoperative pain

  Pain numeric rating scale (NRS) 0-10

  24h after surgery

Secondary Outcomes (8)

• Postoperative pain

  7 days after surgery

• Postoperative pain

  3 months after surgery

• Patient satisfaction

  7 days after surgery

• Patient satisfaction

  3 months after surgery

• Analgesic consumption

  24h after surgery

Interventions

Midazolam injection DRUG

The dose of preoperative midazolam is the predictor variable and will be registered as a continuous variable in a single cohort.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive adult patients proposed for open inguinal hernia repair in Portuguese ambulatory surgery units, under general or spinal anesthesia.

You may qualify if:

• \- adults proposed for open inguinal hernia repair in Portuguese ambulatory surgery units

You may not qualify if:

• psychiatric disorders
• alcoholism
• illiteracy or poor understanding of the Portuguese language
• history of chronic pain under opioids
• recurrent surgery

Sponsors & Collaborators

• Universidade do Porto: lead

Study Sites (4)

Centro Hospitalar Baixo Vouga, EPE

Aveiro, Portugal

Location

Centro Hospitalar Universitário do Algarve

Faro, Portugal

Location

Centro Hospitalar Entre Douro e Vouga, EPE

Santa Maria da Feira, Portugal

Location

Centro Hospitalar Vila Nova de Gaia / Espinho, EPE

Vila Nova de Gaia, Portugal

Location

Related Publications (9)

• 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.

  PMID: 6121598 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.

  PMID: 11037766 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.

  PMID: 10323274 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.

  PMID: 23314164 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.

  PMID: 10861157 BACKGROUND

• Coulthard P, Rood JP. An investigation of the effect of midazolam on the pain experience. Br J Oral Maxillofac Surg. 1992 Aug;30(4):248-51. doi: 10.1016/0266-4356(92)90268-n.

  PMID: 1510899 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.

  PMID: 24882605 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.

  PMID: 21188440 BACKGROUND

• Ong CK, Seymour RA, Tan JM. Sedation with midazolam leads to reduced pain after dental surgery. Anesth Analg. 2004 May;98(5):1289-93, table of contents. doi: 10.1213/01.ane.0000111107.18755.cc.

  PMID: 15105203 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Hernia, Inguinal

Interventions

Midazolam

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Caroline Dahlem, MD

  UPorto /CINTESIS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 9, 2018
• First Posted: April 17, 2018
• Study Start: September 12, 2018
• Primary Completion: June 5, 2020
• Study Completion: March 5, 2021
• Last Updated: May 18, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 6 months following article publication.
• Access Criteria: Proposals should be directed to caroline.dahlem@gmail.com. To gain access, data requestors will need to sign a data access agreement.

Locations

PT (4)