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

NCT ID: NCT03067103

Last Updated: 2017-05-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-01
• Study Completion Date: 2019-05-01

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Tramadol

Intervention Type: DRUG

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

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.

Group Type: ACTIVE_COMPARATOR

Ketamine

Intervention Type: DRUG

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

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.

Group Type: PLACEBO_COMPARATOR

Placebos

Intervention Type: DRUG

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

Interventions

Tramadol

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

Intervention Type: DRUG

Ketamine

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

Intervention Type: DRUG

Placebos

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

Intervention Type: DRUG

Other Intervention Names

group 1; Group 2; Group 3

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidade Federal de Goias

OTHER

Sponsor Role: lead

Responsible Party

juliana alves de sousa caixeta

Medical assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

juliana a caixeta, MD

Role: PRINCIPAL_INVESTIGATOR

Assistant Doctor

Locations

Juliana Alves de Sousa Caixeta

Anápolis, Goiás, Brazil

Countries

Brazil

Central Contacts

juliana a caixeta, MD

Role: CONTACT

jualves39@yahoo.com.br

+5562982706980

Facility Contacts

juliana A caixeta, MD

Role: primary

jualves39@yahoo.com.br

+5562982706980

References

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.

Reference Type: BACKGROUND

PMID: 24041860 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25569408 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22522994 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22989763 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25139134 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23930866 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24303433 (View on PubMed)

Other Identifiers

48547215.0.0000.5076

Identifier Type: OTHER

Identifier Source: secondary_id

JASC1

Identifier Type: -

Identifier Source: org_study_id