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

NCT03067103 | Unknown Phase 4

• 2 other identifiers: JASC148547215.0.0000.5076
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Adenotonsillectomy; pain; topic analgesia; child

Outcome Measures

Primary Outcomes (1)

• 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;

  24h

Secondary Outcomes (1)

• Peritonsillar infiltration of tramadol reduces postoperative pain in children undergone

  24h

Study Arms (3)

tramadol

ACTIVE COMPARATOR

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

ketamine

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Tramadol DRUG

Patients will receive injections in peritonsillar fossa of tramadol (2 mg/kg-2 ml)

Also known as: group 1

tramadol

Ketamine DRUG

Patients will receive injections in peritonsillar fossa of ketamine prior to surgery

Also known as: Group 2

ketamine

Placebos DRUG

Patients will receive 2mL of saline solution in peritonsillar fossa prior to surgery

Also known as: Group 3

Placebo

Eligibility Criteria

• Age: 3 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Sleep disordered breathing
• ASA I-II

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidade Federal de Goias: lead

Study Sites (1)

Juliana Alves de Sousa Caixeta

Anápolis, Goiás, 75110-520, Brazil

Location

Related Publications (7)

• 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.

  PMID: 24041860 BACKGROUND

• 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.

  PMID: 25569408 BACKGROUND

• 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.

  PMID: 22522994 BACKGROUND

• 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.

  PMID: 22989763 BACKGROUND

• 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.

  PMID: 25139134 BACKGROUND

• 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.

  PMID: 23930866 BACKGROUND

• 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.

  PMID: 24303433 BACKGROUND

MeSH Terms

Conditions

Sleep Wake Disorders; Pain, Postoperative; Pain

Interventions

Tramadol; Ketamine

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Postoperative Complications; Pathologic Processes

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Dimethylamines; Methylamines; Amines; Lipids; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• juliana a caixeta, MD

  Assistant Doctor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

juliana a caixeta, MD

CONTACT

+5562982706980; jualves39@yahoo.com.br

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical assistant

Model Details: Patientes will be seleted to receive peritonsillar injection of Tramadol, Ketamine or Placebo before tonsillectomy prospective, double-blind, placebo controlles

Study Record Dates

• First Submitted: February 12, 2017
• First Posted: March 1, 2017
• Study Start: July 1, 2017
• Primary Completion: July 1, 2017
• Study Completion: May 1, 2019
• Last Updated: May 3, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)