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NCT02953145
The Use of Fibrin Sealant to Reduce Post Operative Pain in Cleft Palate Surgery
Phase 4 trial testing Tisseel in Cleft Palate. Withdrawn.
1 September 2020
Quick facts
| Lead sponsor | University of Alberta |
|---|---|
| Phase | Phase 4 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Start date | 1 September 2019 |
| Primary completion | 1 September 2020 |
| Estimated completion | 1 December 2020 |
| Sites | 1 location across Canada |
Drugs / interventions tested
- Tisseel — full drug profile →
Conditions studied
- Cleft Palate — all drugs for Cleft Palate →
Sponsor
University of Alberta
Who can join
Adults 6 Months to 5, any sex, with Cleft Palate. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Cleft Palate is a condition which affects up to 1 in 500 live births. Current treatment is surgery to correct the underlying anomaly. Children born with cleft palate typically undergo surgery at age 12 months. Standard ways to stop surgical bleeding include direct pressure and the use of electrocautery (burning of the tissue). Other products are available to help lessen blood loss. One of these includes a fibrin sealant. Fibrin is the key component of a blood clot. When a fibrin sealant is applied there are a variety of potential benefits other than bleeding control. One of these is decreased pain post operatively It is the investigators belief that the use of a fibrin sealant, Tisseel, in cleft palate surgery will decrease pain and enhance the recovery of children who undergo cleft palate repair. The proposed study will randomly select children undergoing cleft palate repair to have tisseel used on the incision. Through statistical tests 40 children will be recruited (20 to have tisseel used and 20 with no tisseel). The use of tisseel will be known to the surgeon but not to the recovery room or ward nursing staff. Post operatively, the FLACC pain scale will be used to score the pain of the children throughout their admission to the Stollery children's hospital. The amount of pain controlling medication required as well as time to discharge will also be recorded. Statistical analysis of the data will be performed using accepted methods. Overall, the investigators hope to show that fibrin sealant, tisseel, will less the amount of post operative pain experienced by children undergoing cleft palate repair.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT02953145
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Related trials
Other trials of Tisseel
Trials testing the same drug.
- NCT03733639 — Tisseel® as a Reinforcement of Esophagojejunal Anastomoses · Phase 4 · unknown
- NCT03310060 — Reducing Blood Loss Using Tisseel in TKA · Phase 4 · unknown
Other recruiting trials for Cleft Palate
Currently open trials in the same condition.
- NCT06962306 — Optimizing Perioperative Analgesia to Lower Pain Following Cleft Palate Surgery · Phase 4 · recruiting
- NCT06856330 — Effect of Furlow Palatoplasty With Buccal Myomucosal Flap on the Speech Development · recruiting
- NCT06420336 — QL vs LAI for Palatoplasty · NA · recruiting
- NCT05778903 — Maxillary Nerve Blocks in Children - An MRI Study of the Suprazygomatic Approach · NA · recruiting
- NCT04928391 — A Single Bolus of Dexmedetomidine Versus Normal Saline in Postoperative Agitation · Phase 3 · recruiting
Other University of Alberta trials
Trials by the same sponsor.
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- NCT04231760 — The Effect of Inhaled Nitric Oxide on Pulmonary Gas-exchange in COPD · Phase 1, PHASE2 · not yet recruiting
- NCT06649604 — Reducing Pain From Retinal Laser With Vibrational Stimulation · NA · not yet recruiting
- NCT06824077 — Reducing Days DELirious With DEXmedetomidine as Part of an Intensive Care Unit Sleep Promotion Bundle · EARLY_PHASE1 · not yet recruiting
- NCT06920914 — Effects of Minimally vs. Ultra-Processed Diets on Potassium (K) Handling in CKD · NA · not yet recruiting
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 NCT02953145 (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 University of Alberta
- Last refreshed: 20 May 2022
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/NCT02953145.
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