Intravenous Lidocaine in Children Undergoing Laparoscopic Appendectomy
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|ClinicalTrials.gov Identifier: NCT03886896|
Recruitment Status : Completed
First Posted : March 22, 2019
Last Update Posted : May 19, 2020
|Condition or disease||Intervention/treatment||Phase|
|Acute Appendicitis Postoperative Pain Postoperative Nausea and Vomiting||Drug: Lidocaine||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||74 participants|
|Intervention Model:||Parallel Assignment|
|Primary Purpose:||Supportive Care|
|Official Title:||Efficacy of Intravenous Lidocaine Infusion on Pain Relief in Children Undergoing Laparoscopic Appendectomy: Randomized Controlled Trial.|
|Actual Study Start Date :||March 22, 2019|
|Actual Primary Completion Date :||January 15, 2020|
|Actual Study Completion Date :||January 17, 2020|
Experimental: Group A - lidocaine group
Group A: children receiving standard general anesthesia with intravenous lidocaine infusion 1,5 mg/kg for 5 minutes before induction of anesthesia. After 5 minutes, lidocaine infusion continued at rate of 1.5 mg/kg/h during operation, and discontinued before move the patients to PACU.
Lidocaine infusion during surgery
Other Name: Intravenous lidocaine infusion
No Intervention: Group B - control group
Group B: children receiving standard general anesthesia (involving fentanyl and sevoflurane) without lidocaine infusion
- Postoperative opioid consumption [ Time Frame: 24 hours after surgery ]Total nalbuphine requirement in milligrams during the first 24 hours after surgery
- Intraoperative opioid consumption [ Time Frame: Intraoperative - from induction of anesthesia to extubation ]Intraoperative fentanyl consumption - amount of fentanyl in micrograms/kilogram participant's body weight
- Intraoperative volatile anesthetic consumption [ Time Frame: Intraoperative - from induction of anesthesia to extubation ]Intraoperative sevoflurane consumption in milliliters. Investigators use a standard protocol of fresh gas flow.
- Time to first perception of significant pain [ Time Frame: 24 hours after surgery ]Time 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) [ Time Frame: 24 hours after surgery ]Evaluated on a four-point ordinal scale. 0 = none, 1 = nausea, 2 = vomiting 1/hr, 3 = vomiting > 1/hr
- Side effects of lidocaine will be documented [ Time Frame: 24 hours after surgery ]Number of Participants with: headedness, tinnitus, perioral numbness, arrythmia.
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): NCT03886896
|University Clinic Centre of Medical University of Warsaw|
|Warsaw, Poland, 02-091|
|Principal Investigator:||Maciej Kaszyński||Medical University of Warsaw|