Does Midazolam Affect Postoperative Pain?

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03499730
• Other study ID #: Midazolam OBS
• Status: Completed
• Start date: September 12, 2018
• Est. completion date: March 5, 2021

Study information

• Verified date: May 2021
• Source: Universidade do Porto
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

The investigators hypothesize that patients being administered higher midazolam doses will refer more pain.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: March 5, 2021
• Est. primary completion date: June 5, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• psychiatric disorders

• alcoholism

• illiteracy or poor understanding of the Portuguese language

• history of chronic pain under opioids

• recurrent surgery

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

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

Locations

Country	Name	City	State
Portugal	Centro Hospitalar Baixo Vouga, EPE	Aveiro
Portugal	Centro Hospitalar Universitário do Algarve	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

Sponsors (1)

Lead Sponsor	Collaborator
Universidade do Porto

Country where clinical trial is conducted

Portugal, 

References & Publications (9)

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative pain	Pain numeric rating scale (NRS) 0-10	24h after surgery
Secondary	Postoperative pain	Pain NRS	7 days after surgery
Secondary	Postoperative pain	Pain NRS	3 months after surgery
Secondary	Patient satisfaction	NRS	7 days after surgery
Secondary	Patient satisfaction	NRS	3 months after surgery
Secondary	Analgesic consumption	Total analgesic drugs taken in a time period	24h after surgery
Secondary	Analgesic consumption	Total analgesic drugs taken in a time period	7 days after surgery
Secondary	Adverse events	Number of patients with adverse events like bleeding, nausea, uncontrolled pain	7 days after surgery
Secondary	Global surgery recovery index	Global surgery recovery index	3 months after surgery