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NCT03067103

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

Status unknown Phase 4 Last updated 3 May 2017
What this trial tests

Phase 4 trial testing Tramadol in Sleep Disorder; Breathing-Related in 108 participants. Status unknown.

Timeline
1 July 2017
Primary endpoint
1 July 2017
1 May 2019

Quick facts

Lead sponsorUniversidade Federal de Goias
PhasePhase 4
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designsequential
Maskingtriple
Primary purposetreatment
Enrollment108
Start date1 July 2017
Primary completion1 July 2017
Estimated completion1 May 2019
Sites1 location across Brazil

Drugs / interventions tested

Conditions studied

Sponsor

Universidade Federal de Goias — full company profile →

Who can join

Adults 3 to 11, any sex, with Sleep Disorder; Breathing-Related or Pain, Postoperative. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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; 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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other trials of Tramadol

Trials testing the same drug.

Other recruiting trials for Sleep Disorder; Breathing-Related

Currently open trials in the same condition.

Other Universidade Federal de Goias trials

Trials by the same sponsor.

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Data sources for this page

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