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Intravenous Lidocaine in Children Undergoing Laparoscopic Appendectomy

Efficacy of Intravenous Lidocaine Infusion on Pain Relief in Children Undergoing Laparoscopic Appendectomy: Randomized Controlled Trial.

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03886896
Enrollment
74
Registered
2019-03-22
Start date
2019-03-22
Completion date
2020-01-17
Last updated
2020-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Appendicitis, Postoperative Nausea and Vomiting, Postoperative Pain

Keywords

systemic lidocaine, nalbuphine, postoperative pain, multimodal analgesia, laparoscopic appendectomy, laparoscopy, recovery

Brief summary

Intravenous lidocaine - a potent local anesthetic with analgesic and anti-inflammatory properties has been shown to be an effective adjunct that reduces intra and postoperative opioid consumption and facilitates pain management in adults. In children population promising but limited evidence is available. The study was planned to evaluate the efficacy of continuous intravenous infusion of lidocaine to reduce opioid consumption during and after laparoscopic appendectomy in children.

Detailed description

Postoperative pain in children is still one of the most under diagnosed and under treated medical problems. It affects post-surgery recovery, mortality and morbidity, limits mobility. Untreated pain not only causes child's suffering but can decrease the pain threshold in the future or lead to the development of chronic pain. Postoperative analgesia has been traditionally based on opioids but as their use can be associated with adverse effects prolonging hospital stay and affecting recovery current guidelines focus on multimodal approaches involving numerous analgesics with different mechanism of action. Growing evidence suggests that intravenous lidocaine reduces intra- and postoperative requirement for opioids. Lidocaine has been proved to have analgesic and anti-inflammatory properties. It is also a potent peripheral nervous system modulator inhibiting peripheral and central sensitization. The studies performed in adult population have proved the efficacy of systemic lidocaine in postoperative pain treatment. It is an effective adjunct that reduces opioids consumption and facilitates pain management. As such lidocaine infusion has been included in postoperative pain management guidelines for adults. Studies on children population have promising results but high quality randomized controlled trials are still missing. The proposed study has been planned to evaluate the efficacy of continuous infusion of lidocaine as an adjunct to standard general anesthesia (involving fentanyl and sevoflurane) in reducing opioids consumption and facilitating postoperative pain control in children undergoing laparoscopic appendectomy.

Interventions

DRUGLidocaine

Lidocaine infusion during surgery

Sponsors

Medical University of Warsaw
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Months to 18 Years
Healthy volunteers
No

Inclusion criteria

1. Age between 18 months and 18 year-old 2. Patients with American Society of Anaesthesiologists physical status (ASA) class 1/1E, 2/2E, 3/3E 3. Patients undergoing laparoscopic appendectomy

Exclusion criteria

1. Allergy to local anesthetics or contraindication to use of lidocaine 2. Patients with American Society of Anaesthesiologists physical status (ASA) IV or more. 3. Severe cardiovascular disease 4. Preoperative bradycardia 5. Preoperative atrioventricular block 6. Renal failure 7. Chronic treatment with analgesics 8. Parents' refusal

Design outcomes

Primary

MeasureTime frameDescription
Postoperative opioid consumption24 hours after surgeryTotal nalbuphine requirement in milligrams during the first 24 hours after surgery

Secondary

MeasureTime frameDescription
Intraoperative opioid consumptionIntraoperative - from induction of anesthesia to extubationIntraoperative fentanyl consumption - amount of fentanyl in micrograms/kilogram participant's body weight
Intraoperative volatile anesthetic consumptionIntraoperative - from induction of anesthesia to extubationIntraoperative sevoflurane consumption in milliliters. Investigators use a standard protocol of fresh gas flow.
Time to first perception of significant pain24 hours after surgeryTime to first dose of nalbuphine - pain score \> 3 points. Assessing Face - Legs - Activity - Crying - Consolability Scale/Numerical Rating Scale/Visual Analog Pain Scale depending on participant's age.
Incidence of postoperative nausea and vomiting (PONV)24 hours after surgeryEvaluated on a four-point ordinal scale. 0 = none, 1 = nausea, 2 = vomiting 1/hr, 3 = vomiting \> 1/hr
Side effects of lidocaine will be documented24 hours after surgeryNumber of Participants with: headedness, tinnitus, perioral numbness, arrythmia.

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026