Value of indomethacin suppository for preoperative analgesia and anti-inflammation in laparoscopic appendectomy: a protocol of prospective, double-blinded, single-centre, randomised controlled trial in China.
BMJ Open
; 13(8): e069187, 2023 08 07.
Article
in En
| MEDLINE
| ID: mdl-37550026
ABSTRACT
INTRODUCTION:
Postoperative pain has always been a problem for patients and surgeons. Local inflammation, surgical trauma and pain in the body can cause a systemic stress response and immune imbalance, which can affect the patient's rapid recovery. Currently, most of the perioperative pain management is focused on the postoperative phase. The non-steroidal anti-inflammatory drug indomethacin suppository has antipyretic and analgesic effects. This study will evaluate the value of indomethacin suppository for analgesia and anti-inflammation before laparoscopic appendectomy (LA). METHODS ANDANALYSIS:
A single-centre, double-blinded (clinician, assessor, data entry), randomised controlled trial will be conducted in 128 adult patients undergoing LA under emergency general anaesthesia with a Visual Analogue Scale (VAS) >2. The trial was divided into two groups (n=64) using a randomised number table group A will be given 100 mg of indomethacin suppository rectally and group B will be given 8 mg of intravenous lornoxicam. The postoperative analgesic effect, inflammatory response and incidence of postoperative adverse effects will be compared. ETHICS AND DISSEMINATION The study is in accordance with the Declaration of Helsinki and will be conducted in accordance with the principles of Good Clinical Practice. This trial was approved by the Ethics Committee of Beijing Luhe Hospital, Capital Medical University (2021-LHKY-123-02). We will disseminate our study findings at national and international paediatric research conferences. TRIAL REGISTRATION NUMBER Chinese Clinical Trial Registry (ChiCTR2200062004).Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Laparoscopy
/
Analgesia
Type of study:
Clinical_trials
/
Etiology_studies
/
Observational_studies
/
Risk_factors_studies
Aspects:
Ethics
Limits:
Adult
/
Child
/
Humans
Language:
En
Journal:
BMJ Open
Year:
2023
Document type:
Article
Affiliation country:
China