Efficacy of Dexmedetomidine Versus Morphine as an Adjunct to Bupivacaine in Caudal Anesthesia.

• Sponsor: Cairo University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04445636
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Actual Duration (Months): 5.4
• Patients Per Site Per Month: 9.2

Study Details

Study Description

Brief Summary

The aim of this study is to compare the duration of postoperative analgesia, and any side effects of caudal dexmedetomidine versus morphine in combination with bupivacaine in pediatric patients undergoing thoracic surgeries.

Condition or Disease	Intervention/Treatment	Phase
Anesthesia, Local	Drug: Dexmedetomidine; Drug: Morphine	N/A

Detailed Description

The patients will be randomized in a blinded fashion to get enrolled into 2 equal groups:

Group A patients (n =25) will receive caudal epidural analgesia using dexmedetomidine with bupivacaine, whereas Group B patients (n = 25) will receive caudal epidural analgesia using morphine with bupivacaine.

Randomization will be achieved by using an online random number generator. Patient codes will be placed into sequentially numbered sealed opaque envelopes by a research assistant who is not involved in the study. An anesthesia resident not involved in patient management will be responsible for opening the envelope. The anesthesia resident will prepare the study drug according to the instructions contained within each envelope and give it to the anesthesiologist.

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: Randomization will be achieved by a statistician using an online random number generator. Patient codes will be placed into sequentially numbered sealed opaque envelopes by a research assistant who is not involved in the study. An anesthesia resident not involved in patient management will be responsible for opening the envelope. The anesthesia resident will prepare the study drug according to the instructions contained within each envelope and give it to the anesthesiologist.
• Primary Purpose: Treatment
• Official Title: Efficacy of Dexmedetomidine Versus Morphine as an Adjunct to Bupivacaine in Caudal Anesthesia for Pediatric Thoracic Surgeries. A Randomized Controlled Trial.
• Actual Study Start Date: Jun 28, 2020
• Actual Primary Completion Date: Dec 1, 2020
• Actual Study Completion Date: Dec 10, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dexmedetomidine group A group which will receive dexamedetomidine as an adjunct to bupivacaine used in caudal anesthesia.	Drug: Dexmedetomidine; Caudal block with Dexametomedine as an adjuvant to bupivacaine.; Other Names: Precedex
Experimental: Morphine group A group which will receive morphine as an adjunct to bupivacaine used in caudal anesthesia.	Drug: Morphine; Addition of morphine as adjuvant to bupivacaine during caudal block.

Outcome Measures

Primary Outcome Measures

1. Duration of postoperative analgesia in hours. [3 months]

   Duration of postoperative analgesia in hours.

Secondary Outcome Measures

1. Opioid consumption in the first 24 hours post- operative. [3 months]

   Opioid consumption in the first 24 hours post- operative.

2. The duration of ICU stay in days [3 months]

   The duration of ICU stay in days

3. Pain score FLACC from 0 to 6 [3 months]

   Pain score FLACC from 0 to 6

4. Post operative heart rate [3 months]

   Postoperative heart rate in beat per minute

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Year to 6 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• ASA I, II, III.

• Patients undergoing lung cyst excision.

• Patients undergoing Patent Ductus Arteriosus ligation.

Exclusion Criteria:

• Preoperative mechanical ventilation.

• Preoperative inotropic support

• History of mental retardation or delayed development that may interfere with pain intensity assessment

• Known or suspected coagulopathy,

• Any congenital anomalies of the sacrum or any infection at the site of injection.

• Known or suspected allergy to any of the studied drugs.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cairo University Hospitals	Cairo		Egypt	11562

Sponsors and Collaborators

• Cairo University

Investigators

• Study Director: AHMED ISMAIL, Lecturer, Cairo University Hospitals

Study Documents (Full-Text)

None provided.

More Information

Publications

• Anand VG, Kannan M, Thavamani A, Bridgit MJ. Effects of dexmedetomidine added to caudal ropivacaine in paediatric lower abdominal surgeries. Indian J Anaesth. 2011 Jul;55(4):340-6. doi: 10.4103/0019-5049.84835.
• El Shamaa HA, Ibrahim M. A comparative study of the effect of caudal dexmedetomidine versus morphine added to bupivacaine in pediatric infra-umbilical surgery. Saudi J Anaesth. 2014 Apr;8(2):155-60. doi: 10.4103/1658-354X.130677.
• Nguyen KN, Byrd HS, Tan JM. Caudal analgesia and cardiothoracic surgery: a look at postoperative pain scores in a pediatric population. Paediatr Anaesth. 2016 Nov;26(11):1060-1063. doi: 10.1111/pan.12990. Epub 2016 Aug 23.

• Responsible Party: Ahmed Abdelaziz Ismail, Director, Cairo University
• ClinicalTrials.gov Identifier: NCT04445636
• Other Study ID Numbers: N239-2020
• First Posted: Jun 24, 2020
• Last Update Posted: Dec 22, 2020
• Last Verified: Dec 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Ahmed Abdelaziz Ismail, Director, Cairo University: thoracic surgeries; pediatric caudal; dexmedetomidine
• Additional relevant MeSH terms: Dexmedetomidine; Morphine

Study Results

No Results Posted as of Dec 22, 2020