Does Midazolam Affect Postoperative Pain?
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|ClinicalTrials.gov Identifier: NCT03499730|
Recruitment Status : Recruiting
First Posted : April 17, 2018
Last Update Posted : March 26, 2020
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.
|Condition or disease||Intervention/treatment|
|Pain, Postoperative||Drug: Midazolam injection|
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.
|Study Type :||Observational|
|Estimated Enrollment :||300 participants|
|Official Title:||Does Preoperative Midazolam Dose Affect Postoperative Pain? - a Multicentric Observational Study in Open Inguinal Hernia Repair|
|Actual Study Start Date :||September 12, 2018|
|Actual Primary Completion Date :||March 5, 2020|
|Estimated Study Completion Date :||June 5, 2020|
- Drug: Midazolam injection
The dose of preoperative midazolam is the predictor variable and will be registered as a continuous variable in a single cohort.
- Postoperative pain [ Time Frame: 24h after surgery ]Pain numeric rating scale (NRS) 0-10
- Postoperative pain [ Time Frame: 7 days after surgery ]Pain NRS
- Postoperative pain [ Time Frame: 3 months after surgery ]Pain NRS
- Patient satisfaction [ Time Frame: 7 days after surgery ]NRS
- Patient satisfaction [ Time Frame: 3 months after surgery ]NRS
- Analgesic consumption [ Time Frame: 24h after surgery ]Total analgesic drugs taken in a time period
- Analgesic consumption [ Time Frame: 7 days after surgery ]Total analgesic drugs taken in a time period
- Adverse events [ Time Frame: 7 days after surgery ]Number of patients with adverse events like bleeding, nausea, uncontrolled pain
- Global surgery recovery index [ Time Frame: 3 months after surgery ]Global surgery recovery index
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03499730
|Contact: Caroline Dahlem, MDemail@example.com|
|Centro Hospitalar Baixo Vouga, EPE||Recruiting|
|Contact: Margarida Bettencourt, MD|
|Centro Hospitalar Universitário do Algarve||Recruiting|
|Contact: Alírio Gouveia, MD|
|Centro Hospitalar Entre Douro e Vouga, EPE||Active, not recruiting|
|Santa Maria Da Feira, Portugal|
|Centro Hospitalar Vila Nova de Gaia / Espinho, EPE||Recruiting|
|Vila Nova De Gaia, Portugal|
|Contact: Carmen Oliveira, MD|
|Principal Investigator:||Caroline Dahlem, MD||UPorto /CINTESIS|