Intraperitoneal Dexmedetomidine for Post-laparoscopic Appendicectomy Pain Management in Children

NCT03067740 | Unknown Phase 4

• 1 other identifier: approved on 11 june 2016
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pain, Postoperative

Keywords

appendicectomy; children; local anesthetics; laparoscopy; peritoneum

Outcome Measures

Primary Outcomes (1)

• Postoperative abdominal and/or shoulder VAS pain score

  assessment of changes in pain scores along different time intervals in the postoperative 24 hours

  at the start of postanesthesia care unit (PACU)(0 time), and 2 Hours, 4 Hours, 6 Hours, 12 Hours, and 24 Hours postoperative

Secondary Outcomes (4)

• Time of first request of analgesia.

  from the start of postanesthesia care unit (PACU time) and up to 8 hours

• amount of rescue pethidine consumed

  in 24 Hours postoperative

• Length of hospital stay

  from end of surgery till discharge to home, up to one week

• Sedation score

  at the start of postanesthesia care unit (PACU)(0 time), and 2 Hours, 4 Hours, 6 Hours, 12 Hours, and 24 Hours postoperative

Study Arms (2)

Bupivacaine group

ACTIVE COMPARATOR

intraperitoneal instillation of bupivacaine 0.25% ( 2mg/kg) after excision of the appendix.

Drug: Bupivacaine

Bupivacaine-Dexmedetomidine group

EXPERIMENTAL

intraperitoneal instillation of bupivacaine 0.25% ( 2mg/kg) plus dexmedetomidine 1mcg/kg after excision of the appendix.

Drug: Dexmedetomidine

Interventions

Bupivacaine DRUG

intraperitoneal instillation of bupivacaine 0.25% ( 2mg/kg) after excision of the appendix.

Also known as: Marcaine

Bupivacaine group

Dexmedetomidine DRUG

intraperitoneal instillation of bupivacaine 0.25% ( 2mg/kg) plus dexmedetomidine 1mcg/kg after excision of the appendix.

Also known as: Precidex

Bupivacaine-Dexmedetomidine group

Eligibility Criteria

• Age: 8 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Ali Elnabtity

Jeddah, 21461, Saudi Arabia

RECRUITING

Related Publications (8)

• Witt WP, Weiss AJ, Elixhauser A. Overview of Hospital Stays for Children in the United States, 2012. 2014 Dec. In: Healthcare Cost and Utilization Project (HCUP) Statistical Briefs [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2006 Feb-. Statistical Brief #187. Available from http://www.ncbi.nlm.nih.gov/books/NBK274247/

  PMID: 25695124 BACKGROUND

• Sauerland S, Lefering R, Neugebauer EA. Laparoscopic versus open surgery for suspected appendicitis. Cochrane Database Syst Rev. 2004 Oct 18;(4):CD001546. doi: 10.1002/14651858.CD001546.pub2.

  PMID: 15495014 RESULT

• Tomecka MJ, Bortsov AV, Miller NR, Solano N, Narron J, McNaull PP, Ricketts KJ, Lupa CM, McLean SA. Substantial postoperative pain is common among children undergoing laparoscopic appendectomy. Paediatr Anaesth. 2012 Feb;22(2):130-5. doi: 10.1111/j.1460-9592.2011.03711.x. Epub 2011 Sep 29.

  PMID: 21958060 RESULT

• Alexander JI. Pain after laparoscopy. Br J Anaesth. 1997 Sep;79(3):369-78. doi: 10.1093/bja/79.3.369. No abstract available.

  PMID: 9389858 RESULT

• El-Labban GM, Hokkam EN, El-Labban MA, Morsy K, Saadl S, Heissam KS. Intraincisional vs intraperitoneal infiltration of local anaesthetic for controlling early post-laparoscopic cholecystectomy pain. J Minim Access Surg. 2011 Jul;7(3):173-7. doi: 10.4103/0972-9941.83508.

  PMID: 22022099 RESULT

• Golubovic S, Golubovic V, Cindric-Stancin M, Tokmadzic VS. Intraperitoneal analgesia for laparoscopic cholecystectomy: bupivacaine versus bupivacaine with tramadol. Coll Antropol. 2009 Mar;33(1):299-302.

  PMID: 19408641 RESULT

• Albanese AM, Albanese EF, Mino JH, Gomez E, Gomez M, Zandomeni M, Merlo AB. Peritoneal surface area: measurements of 40 structures covered by peritoneum: correlation between total peritoneal surface area and the surface calculated by formulas. Surg Radiol Anat. 2009 Jun;31(5):369-77. doi: 10.1007/s00276-008-0456-9. Epub 2009 Jan 14.

  PMID: 19142561 RESULT

• Kahokehr A, Sammour T, Soop M, Hill AG. Intraperitoneal use of local anesthetic in laparoscopic cholecystectomy: systematic review and metaanalysis of randomized controlled trials. J Hepatobiliary Pancreat Sci. 2010 Sep;17(5):637-56. doi: 10.1007/s00534-010-0271-7.

  PMID: 20393755 RESULT

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine; Dexmedetomidine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: February 16, 2017
• First Posted: March 1, 2017
• Study Start: June 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: April 1, 2017
• Last Updated: March 1, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)