Comparing Magnesium Sulphate, Dexmedetomidine and Midazolam as adjuvant therapy to caudal Bupivacaine in postoperative analgesia in children undergoing lower abdominal surgery

Determining the effect of adding magnesium sulfate, dexmedetomidine and midazolam to bupivacaine with the caudal method in postoperative control of pain in 2-8 year old children who are candidates for lower abdominal surgery.

Clinical trial, without control group, with three parallel groups, double-blind, randomized, phase 3 on 90 patients, for randomization, sealed envelope method is used.

The study will be conducted in Valiasr, Amir al-Mominin and Amir Kabir Arak hospitals. Randomization and then allocation of patients to the mentioned groups is done by the responsible anesthesia technician. Then the caudal anesthesia is performed by the anesthesiologist who only knows the drugs with labels on them.

The participants are children aged between 2 to 8 years old who are candidates for lower abdominal surgery. No emergency surgery or a surgery longer than 90 minutes is included; the participants are categorized as ASA classes I and II, have no previous history of hypersensitivity to the medications used in this study or suffer from renal, cardiac and congenital diseases. If a patient has to be multiple punctured, they are also omitted from the study.

This study consists of three groups of 30 participants (total of 90 participants), that have been randomized in a double-blind fashion. The first group receives Bupivacaine(0.25%, 0.5 ml/kg) with Magnesium Sulfate(50 μg/kg), the second group receives Bupivacaine with Dexmedetomidine(1 μg/kg) and the third group receives Bupivacaine with Midazolam(50 μg/kg). Then the pain experienced by each group in analyzed with VAS and CHEOPS score.

VAS and CHEOPS score will be different among the three groups, the incident of vomiting, chills, additional analgesic consumption and vital signs might be different among three groups.

Patients are divided into three equal groups completely randomly and with a block pattern in the form of blocks of 6. Randomization is done using the online program at https://www.sealedenvelope.com/. Hiding the random chain is done by the method of opaque envelopes.

This study will be conducted in a double-blind manner. All children who are candidates for lower abdominal surgery, who are referred to the hospitals of Arak University of Medical Sciences as electives, and whose informed consent form is completed by their parents, are included in the study. Using blocks of six, they are divided into three equal groups completely randomly. There are 30 people in each group. Children are intubated by the anesthesia team after general anesthesia by the anesthesiologist. Then they are placed in lateral position and ready for caudal analgesia. Patients are divided into three groups A, B, C. The drugs that are supposed to be used for the caudal block are prepared in advance by the anesthesia technician and only A, B, C labels are placed on them. Then the caudal anesthesia is performed by the anesthesiologist who is the main investigator of the project and does not know the type of injectable drugs and only knows the drugs with labels on them. After the injection, the patient is supine, the surgery is performed, and then the project questionnaires will be filled in by the intern of the project, who does not know about the study groups. The division of patients into three groups A, B, and C and placing them in one of these three groups, in which they receive the desired drug according to their placement, is done by the anesthesiologist of the plan. Therefore, both the supervising anesthesiologist and the intern responsible for the design are both blinded to the groups.

The personal data of the participants and their families will remain completely confidential, and only the information used in the data analysis including age, sex, the response to the medications used, and relevant reactions will be mentioned in the study.

The study will take one year to be completed and the data will be available to the public between 6-9 months afterwards.

Data and documentation will be available to universities, hospitals and scientific institutes. Send feedback

The data at the level printed in the article will be available to scientific institutions and universities, but the private information of the patients will not be sent to any person or institution. The primary raw data and all of the measured variables may be made available to students and researchers upon request from the conducting researcher. The study can be used in systematic analysis, in review studies, in scientific proposals and as a reference in scientific articles and books.

To get more information, including all measured variables and primary data, you can send a message to mitrafazli.md@gmail.com or WhatsApp on 09186293538.

If you wish to access more information, email the author of the article Mitra Fazli via the E-mail, mitrafazli.md@gmail.com with the subject "Correspondence about the article comparing adjuvant treatments in the caudal block method in pediatric" by mentioning the academic rank and the purpose of further access. If a response isn't delivered within 2-4 weeks, send a message to WhatsApp via the phone number 09186293538. Phonecalls and SMS will not be answered.