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Intraperitoneal Dexmedetomidine for Post-laparoscopic Appendicectomy Pain Management in Children

This study is currently recruiting participants.
Verified February 2017 by Ali Elnabtity, Zagazig University
Sponsor:
ClinicalTrials.gov Identifier:
NCT03067740
First Posted: March 1, 2017
Last Update Posted: March 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Ali Elnabtity, Zagazig University
  Purpose
Fifty two children of American Society of Anesthesiologists (ASA) physical status I and II, aged 8-14 years old, of both gender, with suspected acute appendicitis scheduled for laparoscopic appendicectomy, were included in this study. Patients were randomized into group (B) and group (BD) with a 1:1 allocation ratio.At the end of surgery, and after peritoneal lavage, those patients who were allocated to B group (bupivacaine group; n = 26) received bupivacaine 0.25% intraperitoneally at a dose of 2 mg/kg followed by 5 ml normal saline. However, in group BD (bupivacaine, Dexmedetomidine group; n = 26), bupivacaine 0.25% at a dose of 2mg/kg was instilled intraperitoneally followed by dexmedetomidine 1mcg/kg diluted in 5 ml normal saline. In the postoperative period, assessments were made for pain and sedation on awakening in PACU (0 time) and at 2, 4, 6, 12,and 24 h. Abdominal and/or shoulder pain was assessed on the 10-cm Visual Analog Scale (VAS). Sedation was assessed using the Ramsay sedation score. Also the occurrence of nausea or vomiting was recorded . The time from extubation to the first administration of pethidine was registered. The consumption of postoperative analgesia was recorded. Side effects of the study drugs were assessed and recorded by the ward nurses for 24h postoperatively. Possible complications such as respiratory depression, allergic reactions, local anaesthetic toxicity,dizziness, , headache, were recorded and managed accordingly. Duration of surgery and length of stay in PACU were noted. Before discharge to home, length of stay in the hospital was recorded and parent's satisfaction was assessed using the 7‑point Likert scale

Condition Intervention Phase
Pain, Postoperative Drug: Bupivacaine Drug: Dexmedetomidine Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intraperitoneal Dexmedetomidine as an Adjuvant to Bupivacaine for Management of Pain in Children Undergoing Laparoscopic Appendicectomy: A Prospective Randomized Trial

Resource links provided by NLM:


Further study details as provided by Ali Elnabtity, Zagazig University:

Primary Outcome Measures:
  • Postoperative abdominal and/or shoulder VAS pain score [ Time Frame: at the start of postanesthesia care unit (PACU)(0 time), and 2 Hours, 4 Hours, 6 Hours, 12 Hours, and 24 Hours postoperative ]
    assessment of changes in pain scores along different time intervals in the postoperative 24 hours


Secondary Outcome Measures:
  • Time of first request of analgesia. [ Time Frame: from the start of postanesthesia care unit (PACU time) and up to 8 hours ]
    when VAS becomes more than 3, analgesia is given and the time is recorded

  • amount of rescue pethidine consumed [ Time Frame: in 24 Hours postoperative ]
    in milligrams

  • Length of hospital stay [ Time Frame: from end of surgery till discharge to home, up to one week ]
    postoperative stay in hospital (days)

  • Sedation score [ Time Frame: at the start of postanesthesia care unit (PACU)(0 time), and 2 Hours, 4 Hours, 6 Hours, 12 Hours, and 24 Hours postoperative ]
    Ramsay Sedation Score (RSS)


Estimated Enrollment: 56
Actual Study Start Date: June 2016
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Bupivacaine group
intraperitoneal instillation of bupivacaine 0.25% ( 2mg/kg) after excision of the appendix.
Drug: Bupivacaine
intraperitoneal instillation of bupivacaine 0.25% ( 2mg/kg) after excision of the appendix.
Other Name: Marcaine
Experimental: Bupivacaine-Dexmedetomidine group
intraperitoneal instillation of bupivacaine 0.25% ( 2mg/kg) plus dexmedetomidine 1mcg/kg after excision of the appendix.
Drug: Dexmedetomidine
intraperitoneal instillation of bupivacaine 0.25% ( 2mg/kg) plus dexmedetomidine 1mcg/kg after excision of the appendix.
Other Name: Precidex

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients are of American Society of Anesthesiologists (ASA) physical status I and II, aged 8-14 years old, of both gender, with suspected acute appendicitis scheduled for laparoscopic appendicectomy.

Exclusion Criteria:

  • The diagnosis of developmental delay, attention deficit disorder, chronic pain, psychiatric illness, previous open abdominal surgery, the presence of a gastrostomy, ventricular-peritoneal shunt or other abdominal prosthesis, immunosuppression, and those allergic to any of the medications.
  Contacts and Locations
Information from the National Library of Medicine

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): NCT03067740


Locations
Saudi Arabia
Ali Elnabtity Recruiting
Jeddah, Saudi Arabia, 21461
Contact: Amr Keera    00966593258958    amrkeera@yahoo.com   
Sponsors and Collaborators
Zagazig University
  More Information

Publications:
1-Witt WP, Weiss AJ, Elixhauser A. Overview of Hospital Stays for Children in the United States, 2012. HCUP Statistical Brief #187. Rockville, MD: Agency for Healthcare Research and Quality; 2014

Responsible Party: Ali Elnabtity, Principal investigator, Zagazig University
ClinicalTrials.gov Identifier: NCT03067740     History of Changes
Other Study ID Numbers: approved on 11 june 2016
First Submitted: February 16, 2017
First Posted: March 1, 2017
Last Update Posted: March 1, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
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 Ali Elnabtity, Zagazig University:
appendicectomy
children
local anesthetics
laparoscopy
peritoneum

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Bupivacaine
Dexmedetomidine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Hypnotics and Sedatives
Analgesics, Non-Narcotic
Analgesics
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action