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

Primary Purpose

Sleep Disorder; Breathing-Related, Pain, Postoperative, Child, Only

Status
Unknown status
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Tramadol
Ketamine
Placebos
Sponsored by
Universidade Federal de Goias
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Disorder; Breathing-Related focused on measuring Adenotonsillectomy, pain, topic analgesia, child

Eligibility Criteria

3 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Juliana Alves de Sousa Caixeta

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

tramadol

ketamine

Placebo

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Peritonsillar infiltration of ketamine reduces postoperative pain in children undergone adenotonsillectomy
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

Peritonsillar infiltration of tramadol reduces postoperative pain in children undergone
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;

Full Information

First Posted
February 12, 2017
Last Updated
May 1, 2017
Sponsor
Universidade Federal de Goias
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1. Study Identification

Unique Protocol Identification Number
NCT03067103
Brief Title
Comparison of Peritonsillar Infiltration of Tramadol Ketamine and Placebo on Pediatric Posttonsillectomy Pain
Official Title
Comparison of Effect of Peritonsillar Infiltration of Ketamine and Tramadol on Pediatric Posttonsillectomy Pain: A Double-blinded Randomized Placebo-controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2017 (Anticipated)
Primary Completion Date
July 1, 2017 (Anticipated)
Study Completion Date
May 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal de Goias

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Disorder; Breathing-Related, Pain, Postoperative, Child, Only
Keywords
Adenotonsillectomy, pain, topic analgesia, child

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Sequential Assignment
Model Description
Patientes will be seleted to receive peritonsillar injection of Tramadol, Ketamine or Placebo before tonsillectomy prospective, double-blind, placebo controlles
Masking
ParticipantCare ProviderInvestigator
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
Allocation
Randomized
Enrollment
108 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
tramadol
Arm Type
Active Comparator
Arm Description
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.
Arm Title
ketamine
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Tramadol
Other Intervention Name(s)
group 1
Intervention Description
Patients will receive injections in peritonsillar fossa of tramadol (2 mg/kg-2 ml)
Intervention Type
Drug
Intervention Name(s)
Ketamine
Other Intervention Name(s)
Group 2
Intervention Description
Patients will receive injections in peritonsillar fossa of ketamine prior to surgery
Intervention Type
Drug
Intervention Name(s)
Placebos
Other Intervention Name(s)
Group 3
Intervention Description
Patients will receive 2mL of saline solution in peritonsillar fossa prior to surgery
Primary Outcome Measure Information:
Title
Peritonsillar infiltration of ketamine reduces postoperative pain in children undergone adenotonsillectomy
Description
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;
Time Frame
24h
Secondary Outcome Measure Information:
Title
Peritonsillar infiltration of tramadol reduces postoperative pain in children undergone
Description
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;
Time Frame
24h

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
juliana a caixeta, MD
Phone
+5562982706980
Email
jualves39@yahoo.com.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
juliana a caixeta, MD
Organizational Affiliation
Assistant Doctor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Juliana Alves de Sousa Caixeta
City
Anápolis
State/Province
GO
ZIP/Postal Code
75110-520
Country
Brazil
Facility Contact:
First Name & Middle Initial & Last Name & Degree
juliana A caixeta, MD
Phone
+5562982706980
Email
jualves39@yahoo.com.br
First Name & Middle Initial & Last Name & Degree
Melissa A Avelino, PhD
First Name & Middle Initial & Last Name & Degree
Paulo S Sucasas, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24041860
Citation
Ugur KS, Karabayirli S, Demircioglu RI, Ark N, Kurtaran H, Muslu B, Sert H. The comparison of preincisional peritonsillar infiltration of ketamine and tramadol for postoperative pain relief on children following adenotonsillectomy. Int J Pediatr Otorhinolaryngol. 2013 Nov;77(11):1825-9. doi: 10.1016/j.ijporl.2013.08.018. Epub 2013 Aug 27.
Results Reference
background
PubMed Identifier
25569408
Citation
Yenigun A, Et T, Aytac S, Olcay B. Comparison of different administration of ketamine and intravenous tramadol hydrochloride for postoperative pain relief and sedation after pediatric tonsillectomy. J Craniofac Surg. 2015 Jan;26(1):e21-4. doi: 10.1097/SCS.0000000000001250.
Results Reference
background
PubMed Identifier
22522994
Citation
Ayatollahi V, Behdad S, Hatami M, Moshtaghiun H, Baghianimoghadam B. Comparison of peritonsillar infiltration effects of ketamine and tramadol on post tonsillectomy pain: a double-blinded randomized placebo-controlled clinical trial. Croat Med J. 2012 Apr;53(2):155-61. doi: 10.3325/cmj.2012.53.155.
Results Reference
background
PubMed Identifier
22989763
Citation
Heiba MH, Atef A, Mosleh M, Mohamed R, El-Hamamsy M. Comparison of peritonsillar infiltration of tramadol and lidocaine for the relief of post-tonsillectomy pain. J Laryngol Otol. 2012 Nov;126(11):1138-41. doi: 10.1017/S0022215112002058. Epub 2012 Sep 19.
Results Reference
background
PubMed Identifier
25139134
Citation
Tong Y, Ding XB, Wang X, Ren H, Chen ZX, Li Q. Ketamine peritonsillar infiltration during tonsillectomy in pediatric patients: An updated meta-analysis. Int J Pediatr Otorhinolaryngol. 2014 Oct;78(10):1735-41. doi: 10.1016/j.ijporl.2014.07.036. Epub 2014 Aug 1.
Results Reference
background
PubMed Identifier
23930866
Citation
Siddiqui AS, Raees US, Siddiqui SZ, Raza SA. Efficacy of pre-incisional peritonsillar infiltration of ketamine for post-tonsillectomy analgesia in children. J Coll Physicians Surg Pak. 2013 Aug;23(8):533-7.
Results Reference
background
PubMed Identifier
24303433
Citation
Beigh Z, Ul Islam M, Ahmad S, Ahmad Pampori R. Effects of Peritonsillar Injection of Tramadol and Adrenaline before Tonsillectomy. Iran J Otorhinolaryngol. 2013 Jun;25(72):135-40.
Results Reference
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Comparison of Peritonsillar Infiltration of Tramadol Ketamine and Placebo on Pediatric Posttonsillectomy Pain

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