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NCT03067103
Comparison of Peritonsillar Infiltration of Tramadol Ketamine and Placebo on Pediatric Posttonsillectomy Pain
Phase 4 trial testing Tramadol in Sleep Disorder; Breathing-Related in 108 participants. Status unknown.
1 July 2017
Quick facts
| Lead sponsor | Universidade Federal de Goias |
|---|---|
| Phase | Phase 4 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | sequential |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 108 |
| Start date | 1 July 2017 |
| Primary completion | 1 July 2017 |
| Estimated completion | 1 May 2019 |
| Sites | 1 location across Brazil |
Drugs / interventions tested
- Tramadol (tramadol) — full drug profile →
- Ketamine (ketamine) — full drug profile →
- Placebos — full drug profile →
Conditions studied
- Sleep Disorder; Breathing-Related — all drugs for Sleep Disorder; Breathing-Related →
- Pain, Postoperative — all drugs for Pain, Postoperative →
- Child, Only — all drugs for Child, Only →
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.
Verify or expand the search:
- PubMed search for NCT03067103
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Other recruiting trials for Sleep Disorder; Breathing-Related
Currently open trials in the same condition.
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Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03067103 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Universidade Federal de Goias
- Last refreshed: 3 May 2017
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03067103.
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