Recruiting
Phase 1
Phase 2

Nebulized Analgesia

Sponsor:

McGill University Health Centre/Research Institute of the McGill University Health Centre

Code:

NCT02624089

Conditions

Appendicitis

Eligibility Criteria

Sex: All

Age: 7 - 18

Healthy Volunteers: Not accepted

Interventions

Ropivacaine

Normal saline

Study Details

Brief summary:

The objective of this study is to assess whether the administration of nebulized intra-peritoneal ropivacaine at the onset of surgery, compared with nebulized saline, reduces morphine consumption after laparoscopic appendectomy surgery in children and adolescents.

Conditions

Appendicitis

Study ID

NCT02624089

Start date

Jan, 2016

Status verified date

Mar, 2016

Completion date

Jul, 2017

Anticipated

Primary completion date

Jun, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 7 - 18

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Children and adolescents aged 7-18 years old
  • ASA Score I (American Society of Anesthesiologists classification) \[Appendix 1\]: a normal healthy patient.
  • ASA Score II (American Society of Anesthesiologists classification): A patient with mild systemic disease
  • Patients scheduled for laparoscopic appendectomy surgery
  • Uncomplicated appendicitis

  • Hemodynamically stable patient
  • No evidence of appendiceal perforation based on preoperative clinical and imaging assessment
  • Diagnosed to have simple acute appendicitis by intraoperative laparoscopy
  • Patients who have provided a written informed assent
  • Caregivers who have provided a written informed consent

Exclusion Criteria:

  • ASA Score III (American Society of Anesthesiologists classification): A patient with severe systemic disease
  • ASA Score IV (American Society of Anesthesiologists classification): A patient with severe systemic disease that is a constant threat to life
  • ASA Score V (American Society of Anesthesiologists classification): A moribund patient who is not expected to survive without the operation
  • Hemodynamically unstable patient
  • Evidence of appendiceal perforation on based on preoperative clinical and imaging assessment
  • Perforated or gangrenous appendicitis diagnosed during laparoscopic surgery
  • Postoperative admission in an intensive care unit with sedation or ventilatory assistance
  • Cognitive impairment or mental retardation
  • Progressive degenerative diseases of the CNS
  • Seizures or chronic therapy with antiepileptic drugs
  • Severe hepatic or renal impairment
  • Allergy to one of the specific drugs under study
  • Alcohol or drug addiction
  • Failure to successfully undergo a laparoscopic appendectomy
  • A significant communication problem including language barrier, precluding phone follow up
  • Participation in a concomitant research study
  • Inability to assure complete follow up
  • Failure to acquire informed consent and assent

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Ropivacaine Group

This group will receive nebulized ropivacaine 0.5% based on ideal body weight at a dose of 0.5 mg/kg with a maximum total dose of 30 mg. This will be administered once at the onset of pneuomoperitoneum during appendectomy.

placebo comparator: Placebo group

This group will receive placebo (normal saline) based on ideal body weight at a dose of 0.5 mg/kg with a maximum total dose of 30 mg. This will be administered at the onset of pneuomoperitoneum during appendectomy.

no intervention: Non-enrolled group

This group will not receive either intervention (ropivicaine) or placebo (normal saline), but will have primary and secondary endpoints evaluated.

Interventions

Ropivacaine

Ropivicaine will be administered via in-line nebulization using the Aeroneb Pro™ system

Normal saline

Normal saline will be administered via in-line nebulization using the Aeroneb Pro™ system

Primary outcome measure

  • Post-operative morphine consumption [ Time Frame: During hospital admission (24-48 hours) ]

Central Contacts and Locations

Central contacts

Robert Baird, MDCM MSc

514 412 4400robert.baird@mcgill.ca

Pablo Ingelmo, MD

514 412 4400pablo.ingelmo@mcgill.ca

Locations

Montreal Children's Hospital

Recruiting

Montreal, Quebec, Canada, H4A 3J1

Contacts

Robert Baird, MDCM MSc

514 412 4400robert.baird@mcgill.ca

More Information

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Last update posted

Mar 22, 2016

Last verified

Mar, 2016

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McGill University Health Centre/Research Institute of the McGill University Health Centre on 2016-03-22.