Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Systemic midazolam prescribed perioperatively might have impact on pain, with studies suggesting antinociceptive and hyperalgesic effects. Anxiety might be a confounder in this association. In order to investigate the effect of midazolam on postoperative pain, a prospective cohort study will be conducted in four Portuguese ambulatory surgery units. A convenience sample with consecutive design will include patients admitted for open inguinal hernia repair. After anxiety and pain evaluation, a tailored dose of midazolam will be administered as premedication according to the anesthetist's best judgement within each unit's protocol (routine care; this dose may be null). Subsequent anesthesia and analgesia will be standardized. Postoperative pain will be blindly assessed by telephone interviews at 24h, 7 days, and 3 months. Statistical analysis will be performed separately for each gender, centre and type of anesthesia, adjusting for preoperative anxiety and other confounding variables with multivariate analysis.
The investigators intend to clarify the relation between anxiety, preoperative midazolam and postoperative pain.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Midazolam injection | Drug | The dose of preoperative midazolam is the predictor variable and will be registered as a continuous variable in a single cohort. |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pain | Pain numeric rating scale (NRS) 0-10 | 24h after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pain | Pain NRS | 7 days after surgery |
| Postoperative pain | Pain NRS | 3 months after surgery |
Not provided
Inclusion Criteria:
- adults proposed for open inguinal hernia repair in Portuguese ambulatory surgery units
Exclusion Criteria:
Not provided
Not provided
Not provided
Consecutive adult patients proposed for open inguinal hernia repair in Portuguese ambulatory surgery units, under general or spinal anesthesia.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Caroline Dahlem, MD | UPorto /CINTESIS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro Hospitalar Baixo Vouga, EPE | Aveiro | Portugal | ||||
| Centro Hospitalar Universitário do Algarve |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 6121598 | 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. | |
| 11037766 | 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. |
Not provided
Not provided
Individual participant data that underlie the results reported in this article might be shared with other researchers after deidentification.
Beginning 6 months following article publication.
Proposals should be directed to caroline.dahlem@gmail.com. To gain access, data requestors will need to sign a data access agreement.
Not provided
Not provided
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D006552 | Hernia, Inguinal |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
Not provided
Not provided
| ID | Term |
|---|---|
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided
Not provided
Not provided
Not provided
| Patient satisfaction | NRS | 7 days after surgery |
| Patient satisfaction | NRS | 3 months after surgery |
| Analgesic consumption | Total analgesic drugs taken in a time period | 24h after surgery |
| Analgesic consumption | Total analgesic drugs taken in a time period | 7 days after surgery |
| Adverse events | Number of patients with adverse events like bleeding, nausea, uncontrolled pain | 7 days after surgery |
| Global surgery recovery index | Global surgery recovery index | 3 months after surgery |
| Faro |
| Portugal |
| 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 |
| 10323274 | 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. |
| 23314164 | 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. |
| 10861157 | 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. |
| 1510899 | 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. |
| 24882605 | 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. |
| 21188440 | 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. |
| 15105203 | 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. |
| 42244825 | Derived | Dahlem CS, Monteiro CT, Mendes E, Oliveira CC, Bettencourt M, Azevedo L, Berger-Estilita J, Granja C. Comparing two pre-operative anxiety scales for predicting postoperative pain in ambulatory surgery: Data from a multicentre observational study. Eur J Anaesthesiol Intensive Care. 2026 Mar 30;5(3):e0102. doi: 10.1097/EA9.0000000000000102. eCollection 2026 Jun. |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D006571 | Heterocyclic Compounds |