Trials / Completed
CompletedNCT03499730
Does Midazolam Affect Postoperative Pain?
Does Preoperative Midazolam Dose Affect Postoperative Pain? - a Multicentric Observational Study in Open Inguinal Hernia Repair
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 300 (actual)
- Sponsor
- Universidade do Porto · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Midazolam injection | The dose of preoperative midazolam is the predictor variable and will be registered as a continuous variable in a single cohort. |
Timeline
- Start date
- 2018-09-12
- Primary completion
- 2020-06-05
- Completion
- 2021-03-05
- First posted
- 2018-04-17
- Last updated
- 2021-05-18
Locations
4 sites across 1 country: Portugal
Source: ClinicalTrials.gov record NCT03499730. Inclusion in this directory is not an endorsement.