The Use of Fibrin Sealant to Reduce Post Operative Pain in Cleft Palate Surgery

NCT02953145 | Withdrawn Phase 4

• 1 other identifier: 45664
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cleft Palate

Outcome Measures

Primary Outcomes (8)

• Post operative pain

  FLACC scores will be determined by blinded ward nurses and/or caregiver of the patient.

  time 1 hour post operation

• Post operative pain

  FLACC scores will be determined by blinded ward nurses and/or caregiver of the patient.

  time 2 hours post operation

• Post operative pain

  FLACC scores will be determined by blinded ward nurses and/or caregiver of the patient.

  time 4 hours post operation

• Post operative pain

  FLACC scores will be determined by blinded ward nurses and/or caregiver of the patient.

  time 6 hours post operation

• Post operative pain

  FLACC scores will be determined by blinded ward nurses and/or caregiver of the patient.

  time 12 hours post operation

• Post operative pain

  FLACC scores will be determined by blinded ward nurses and/or caregiver of the patient.

  time 24 hours post operation

• Post operative pain

  FLACC scores will be determined by blinded ward nurses and/or caregiver of the patient.

  time 48 hours post operation

• Post operative pain

  FLACC scores will be determined by blinded ward nurses and/or caregiver of the patient.

  time 72 hours post operation

Secondary Outcomes (4)

• Requirement for analgesia

  From immediate post operative period up to 5 days

• Time to discharge

  From immediate post operative period up to 5 days

• Time to first feeding

  From immediate post operative period up to 5 days

• oronasal fistula

  Immediately post operatively until 2 years post operatively.

Study Arms (2)

Tisseel applied

EXPERIMENTAL

In this group, the fibrin sealant Tisseel will be applied as a hemostasis agent in patients undergoing primary palatoplasty

Drug: Tisseel

No fibrin sealant

NO INTERVENTION

In this group, no fibrin sealant will be applied intra-operatively. Standard measures, such as electrocautery, will be used for hemostasis.

Interventions

Tisseel DRUG

Tisseel will be applied to open areas lateral to the cleft palate repair

Also known as: fibrin sealant

Tisseel applied

Eligibility Criteria

• Age: 6 Months - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Undergoing primary cleft palate repair (palatoplasty)
• Informed consent from parent(s) or guardian(s)

You may not qualify if:

• Allergy to any component of Tisseel
• failure to obtain informed consent

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

Stollery Alberta Children's hospital

Edmonton, Alberta, T6G2B7, Canada

Location

Related Publications (5)

• Davis BR, Sandor GK. Use of fibrin glue in maxillofacial surgery. J Otolaryngol. 1998 Apr;27(2):107-12.

  PMID: 9572465 BACKGROUND

• Healy C, Greig AVH, Murphy AD, Powell C, Pinder RJ, Saour S, Abela C, Knight W, Geh JLC. Prospective randomized controlled trial: fibrin sealant reduces split skin graft donor-site pain. Plast Reconstr Surg. 2013 Jul;132(1):139e-146e. doi: 10.1097/PRS.0b013e318299c6f4.

  PMID: 23806933 BACKGROUND

• MacGillivray TE. Fibrin sealants and glues. J Card Surg. 2003 Nov-Dec;18(6):480-5. doi: 10.1046/j.0886-0440.2003.02073.x.

  PMID: 14992096 BACKGROUND

• Merkel SI, Voepel-Lewis T, Shayevitz JR, Malviya S. The FLACC: a behavioral scale for scoring postoperative pain in young children. Pediatr Nurs. 1997 May-Jun;23(3):293-7.

  PMID: 9220806 BACKGROUND

• Moralee SJ, Carney AS, Cash MP, Murray JA. The effect of fibrin sealant haemostasis on post-operative pain in tonsillectomy. Clin Otolaryngol Allied Sci. 1994 Dec;19(6):526-8. doi: 10.1111/j.1365-2273.1994.tb01282.x.

  PMID: 7895385 BACKGROUND

MeSH Terms

Conditions

Cleft Palate

Interventions

Fibrin Tissue Adhesive

Condition Hierarchy (Ancestors)

Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Stomatognathic Diseases; Mouth Abnormalities; Mouth Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Fibrin; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Jaret L Olson, MD FRCSC

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2015
• First Posted: November 2, 2016
• Study Start: September 1, 2019
• Primary Completion: September 1, 2020
• Study Completion: December 1, 2020
• Last Updated: May 20, 2022

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)