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Pain, PostoperativeNCT03499730

Does Midazolam Affect Postoperative Pain?

An observational study of Pain, Postoperative, run by Universidade do Porto at 4 sites in Portugal.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pain, Postoperative
What is being tested?
Midazolam injection
Type of treatment
Injection or infusion
How many people
300 participants
Where
4 sitesPortugal
Study dates
12 Sep 2018to 5 Mar 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

4 sites in 1 country.

Portugal4 sites

  • Centro Hospitalar Baixo Vouga, EPE

    Aveiro

  • Centro Hospitalar Universitário do Algarve

    Faro

  • Centro Hospitalar Entre Douro e Vouga, EPE

    Santa Maria da Feira

  • Centro Hospitalar Vila Nova de Gaia / Espinho, EPE

    Vila Nova de Gaia

Other trials in Portugal

About this study

Official title: Does Preoperative Midazolam Dose Affect Postoperative Pain? - a Multicentric Observational Study in Open Inguinal Hernia Repair

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.

Read the detailed description

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.

Being tested
Midazolam injection
Keywords
Midazolam, Inguinal hernia
Medical subject headings
Pain, Postoperative, Hernia, Inguinal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Midazolam injectionDrug

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Postoperative pain

    Pain numeric rating scale (NRS) 0-10

    Measured: 24h after surgery

Secondary outcomes (8)

  1. Postoperative pain

    Pain NRS

    Measured: 7 days after surgery

  2. Postoperative pain

    Pain NRS

    Measured: 3 months after surgery

  3. Patient satisfaction

    NRS

    Measured: 7 days after surgery

  4. Patient satisfaction

    NRS

    Measured: 3 months after surgery

  5. Analgesic consumption

    Total analgesic drugs taken in a time period

    Measured: 24h after surgery

  6. Analgesic consumption

    Total analgesic drugs taken in a time period

    Measured: 7 days after surgery

  7. Adverse events

    Number of patients with adverse events like bleeding, nausea, uncontrolled pain

    Measured: 7 days after surgery

  8. Global surgery recovery index

    Global surgery recovery index

    Measured: 3 months after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Apr 2018
  2. Study start12 Sep 2018
  3. Primary completion5 Jun 2020
  4. Study completion5 Mar 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03499730
Sponsor's protocol ID
Midazolam OBS
Status last verified
May 2021
First submitted
9 Apr 2018
Last updated
18 May 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data that underlie the results reported in this article might be shared with other researchers after deidentification.

Publications

  • 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.

    PubMed 6121598

  • 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.

    PubMed 11037766

  • 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.

    PubMed 10323274

  • Frolich MA, Zhang K, Ness TJ. Effect of sedation on pain perception. Anesthesiology. 2013 Mar;118(3):611-21. doi: 10.1097/ALN.0b013e318281592d.

    PubMed 23314164

  • 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.

    PubMed 10861157

  • 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.

    PubMed 1510899

  • 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.

    PubMed 24882605

  • 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.

    PubMed 21188440

  • 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.

    PubMed 15105203

  • 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.

    PubMed 42244825

Questions about this trial

What is this clinical trial studying?

An observational study of Pain, Postoperative, run by Universidade do Porto at 4 sites in Portugal.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative pain (time frame: 24h after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03499730, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2021.

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