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Comparison of Peritonsillar Infiltration of Tramadol Ketamine and Placebo on Pediatric Posttonsillectomy Pain

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ClinicalTrials.gov Identifier: NCT03067103
Recruitment Status : Unknown
Verified May 2017 by juliana alves de sousa caixeta, Universidade Federal de Goias.
Recruitment status was:  Not yet recruiting
First Posted : March 1, 2017
Last Update Posted : May 3, 2017
Sponsor:
Information provided by (Responsible Party):
juliana alves de sousa caixeta, Universidade Federal de Goias

Brief Summary:
Adenotonsillectomy is one of the most common ambulatory surgical procedures performed to children. Tonsillectomy or adenotonsillectomy have a high incidence of postoperative pain. There is still debate about the optimal analgesia for this common surgical procedure. Different methods have been described and used to reduce pain including; improved intraoperative anesthetic pain regimens, use of corticosteroids, adjustment of surgical technique, and intraoperative local anesthetic injection. Intraoperative local anesthetic is a preventive or preemptive analgesia which is the analgesia given before painful stimuli to prevent the subsequent pain. The main goal of the preventive analgesia is the pain relief with minimum side effects. The role of local anesthetic infiltration in the reduction of postadenotonsillectomy pain is still controversial. The objective of this study is to investigate and compare the effectiveness of preincisional peritonsillar infiltration of ketamine and tramadol for post-operative pain on children following adenotonsillectomy. This is prospective, double-blinded randomized study.

Condition or disease Intervention/treatment Phase
Sleep Disorder; Breathing-Related Pain, Postoperative Child, Only Drug: Tramadol Drug: Ketamine Drug: Placebos Phase 4

Detailed Description:

Adenotonsillectomy is one of the most common ambulatory surgical procedures performed to children. Tonsillectomy or adenotonsillectomy have a high incidence of postoperative pain. There is still debate about the optimal analgesia for this common surgical procedure. Different methods have been described and used to reduce pain including. The main goal of the preventive analgesia is the pain relief with minimum side effects. The role of local anesthetic infiltration in the reduction of postadenotonsillectomy pain is still controversial. Blockage of N-methyl-D-aspartate (NMDA) activation and interception of nociceptive in put are important factors to achieve the reduction in subsequent pain. Ketamine hydrochloride is an NMDA receptor antagonist. The blockage of the NMDA channel and analgesic properties are both at subanesthetic doses for the ketamine. Ketamine also prevents central sensitization of nociceptors. Previous studies described the analgesic effect of intravenous application or peritonsillar infiltration of ketamine intraoperatively in children after tonsillectomy. Tramadol is another analgesic and a synthetic opioid of the aminocyclohexanol group which is a central opioid agonist with less respiratory depression compared to morphine. We knew that tramadol has both systemic and local anesthetic effect on peripheral nerves from human and animal studies.

The study was approved by the Ethics Committee of the University. The consents will be taken from all parents. Patients will be randomized from seald envelope into tramadol, ketamine or control (serum physiologic) to receive the preincisional peritonsillar infiltration before the surgery. There will de 36 patients in each group. The study drug is supplied of a liquid identical in color and volume. All surgeons, anesthesiologists, nurses, patients and parents will be blinded to study group until the end of the study All children will receive a premedication including midazolam hydrochloride (0.5 mg/kg; maximum dose, 20 mg) followed by a standard general inhalational anesthetic (50% O2-N2O and 8% sevoflurane). Children also received 0.1 mg/kg of fentanyl citrate and 0.2 mg/kg mivacurium intravenously. After the intubation maintenance anesthesia will be keep with nitrous oxide (50%) in oxygen and sevoflurane. All patients will receive the peritonsillar injection of the study drug before the excision of the anesthesia. Tramadol group will receive 2 mg/kg (2 ml), ketamine group 0.5 mg/kg (2cc), control group 2 ml of serum physiologic. All infiltrations will be through the peritonsillar fossa. For each tonsil 1 ml will be applied to upper pole, lower pole and between the upper and lower pole with 25-G needle. After the infiltration surgeons will wait 3 min for tonsillectomy. The same standard blunt dissection will be performed to all children by the same surgeon. During the operation heart rate oxygen saturation, average blood pressure, respiration rates will be recorded in every 5 min. Operation, anesthesia times will also be recorded. Postoperatively pain, nausea, vomiting, sedation scores, the existence of dysphagia, bleeding were recorded at 2, 6, 12, 24 h postoperatively. Children's pain scores will be measured by using Visual Analogue Scale (VAS).If the pain score is greater than 5, Ibuprofen will be given to children. Pains with the request for analgesic requirements, the time of analgesia requirement, patient satisfaction will be also recorded.

Data analysis will be performed by using SPSS for Windows. The relationship between categorical variables will be test by Chi-square test and Anova test will be performed to compare groups according to continuous variables. Also LSD test will be used to detect subgroup differences. p Values higher than 0.05 will be considered as significant. Mean and standard deviations and percentages will be given as descriptive statistics.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Patientes will be seleted to receive peritonsillar injection of Tramadol, Ketamine or Placebo before tonsillectomy prospective, double-blind, placebo controlles
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Patients admitted for tonsillectomy were randomized into 3 groups by means of sealed envelopes. The envelope selected by the caregiver will be open by the registered nurse, who will prepare the infiltration. Neither the surgeon, anesthesiologist the caregiver nor the patient will see what is inside the envelope. The register of the envelope number and patient data will be done by the statistical group
Primary Purpose: Treatment
Official Title: Comparison of Effect of Peritonsillar Infiltration of Ketamine and Tramadol on Pediatric Posttonsillectomy Pain: A Double-blinded Randomized Placebo-controlled Clinical Trial
Estimated Study Start Date : July 1, 2017
Estimated Primary Completion Date : July 1, 2017
Estimated Study Completion Date : May 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: tramadol
Tramadol group will receive 2 mg/kg (2 ml) through the peritonsillar fossa. For each tonsil 1 ml will be applied to upper pole, lower pole and between the upper and lower pole with 25-G needle. The depth of the infiltration will be as superficial as 3 mm of needle injected and ballooned out the submucosal tissues of the tonsillar pillar, intratonsillar injection as avoided.
Drug: Tramadol
Patients will receive injections in peritonsillar fossa of tramadol (2 mg/kg-2 ml)
Other Name: group 1

Active Comparator: ketamine
Ketamine group will receive 0.5 mg/kg (2cc) through the peritonsillar fossa. For each tonsil 1 ml will be applied to upper pole, lower pole and between the upper and lower pole with 25-G needle. The depth of the infiltration will be as superficial as 3 mm of needle injected and ballooned out the submucosal tissues of the tonsillar pillar, intratonsillar injection as avoided.
Drug: Ketamine
Patients will receive injections in peritonsillar fossa of ketamine prior to surgery
Other Name: Group 2

Placebo Comparator: Placebo
Placebo group will receive 2mL of saline solution through the peritonsillar fossa. For each tonsil 1 ml will be applied to upper pole, lower pole and between the upper and lower pole with 25-G needle. The depth of the infiltration will be as superficial as 3 mm of needle injected and ballooned out the submucosal tissues of the tonsillar pillar, intratonsillar injection as avoided.
Drug: Placebos
Patients will receive 2mL of saline solution in peritonsillar fossa prior to surgery
Other Name: Group 3




Primary Outcome Measures :
  1. Peritonsillar infiltration of ketamine reduces postoperative pain in children undergone adenotonsillectomy [ Time Frame: 24h ]
    Children will be evaluated by the Visual Analog Scale of pain and children who had received ketamine should be lower scores when compared to children who had received placebo. These children are expected to ask less times for analgesic medication;


Secondary Outcome Measures :
  1. Peritonsillar infiltration of tramadol reduces postoperative pain in children undergone [ Time Frame: 24h ]
    Children will be evaluated by the Visual Analog Scale of pain and children who had received tramadol should be lower scores when compared to children who had received placebo. These children are expected to ask less times for analgesic medication;



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Ages Eligible for Study:   3 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Sleep disordered breathing
  • ASA I-II

Exclusion Criteria:

  • ASA III-IV physical status
  • Coagulation disturbances
  • Presence of relevant drug allergies
  • pulmonary and cardiac diseases
  • Craniofacial anomalies
  • Mental diseases
  • Genetic disorders
  • Peritonsillar abscess formation
  • Regular use of analgesics 24 h prior to surgery

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): NCT03067103


Contacts
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Contact: juliana a caixeta, MD +5562982706980 jualves39@yahoo.com.br

Locations
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Brazil
Juliana Alves de Sousa Caixeta Not yet recruiting
Anápolis, GO, Brazil, 75110-520
Contact: juliana A caixeta, MD    +5562982706980    jualves39@yahoo.com.br   
Sub-Investigator: Melissa A Avelino, PhD         
Sub-Investigator: Paulo S Sucasas, PhD         
Sponsors and Collaborators
Universidade Federal de Goias
Investigators
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Principal Investigator: juliana a caixeta, MD Assistant Doctor

Publications:

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Responsible Party: juliana alves de sousa caixeta, Medical assistant, Universidade Federal de Goias
ClinicalTrials.gov Identifier: NCT03067103     History of Changes
Other Study ID Numbers: JASC1
48547215.0.0000.5076 ( Other Identifier: intitution's Ehtical approval )
First Posted: March 1, 2017    Key Record Dates
Last Update Posted: May 3, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by juliana alves de sousa caixeta, Universidade Federal de Goias:
Adenotonsillectomy
pain
topic analgesia
child
Additional relevant MeSH terms:
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Tramadol
Sleep Wake Disorders
Pain, Postoperative
Pathologic Processes
Postoperative Complications
Pain
Neurologic Manifestations
Signs and Symptoms
Nervous System Diseases
Mental Disorders
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics