Effect of Tonsillar Pillar Closure on Postoperative Pain and Bleeding Risk After Tonsillectomy

Pain Clinical Trial

Official title:

Effect of Tonsillar Pillar Closure on Postoperative Pain and Bleeding Risk After Tonsillectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00394849
• Other study ID #: 0006-26
• Status: Completed
• Phase: N/A
• First received: October 30, 2006
• Last updated: November 3, 2017
• Start date: July 2000
• Est. completion date: March 2004

Study information

• Verified date: November 2017
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if closing the tonsil fossa after tonsillectomy leads to less pain and bleeding risk than leaving it open to heal by secondary intention.

Description:

After induction of appropriate general anesthesia, a tonsillectomy was performed and control of bleeding was achieved as is routine for the individual Otolaryngologist performing the procedure. Next the surgeon used 3-0 chromic (absorbable) sutures on tapered needles to close one tonsillar fossa but leave the tonsillar fossa on the other side open. The side chosen was determined by a computer generated schedule. Routine postoperative care was given.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 763
• Est. completion date: March 2004
• Est. primary completion date: March 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Any patient for whom tonsillectomy is recommended for recurrent pharyngitis, obstructive sleep disorder, snoring, halitosis, feeding difficulty associated with adenotonsillar hypertrophy, and who in the investigator's opinion, is capable of providing reliable responses to post-operative follow-up questions as defined in this protocol.

Exclusion Criteria:

• Any patient for whom tonsillectomy is recommended for suspected malignancy or active peritonsillar abscess

Related Conditions & MeSH terms

• Hemorrhage
• Pain
• Pain, Postoperative

Intervention

Procedure:
• suture one tonsillar fossa
one tonsillar fossa was sutured. One side was not sutured. Pain was compared side to side.

Locations

Country	Name	City	State
United States	Riley Childrens' Hospital	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University School of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (1)

Matt BH, Krol BJ, Ding Y, Juliar BE. Effect of tonsillar fossa closure on postoperative pain and bleeding risk after tonsillectomy. Int J Pediatr Otorhinolaryngol. 2012 Dec;76(12):1799-805. doi: 10.1016/j.ijporl.2012.09.004. Epub 2012 Sep 25. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	which side was more painful on or about postoperative day 14	determined which side was more painful on or about postoperative day 14 by asking patient and/or care giver	14 days
Secondary	Additional information was obtained about details if postoperative bleeding occurred, including which side bled and details of the event	Additional information was obtained about details if postoperative bleeding occurred. Specifically, if postoperative bleeding occurred, we sought to obtain as many details as possible about the events. Items such as when the postoperative bleeding occurred, what was done about it, where the subject was treated, and what the outcome was ( was the bleeding controlled, did the subject have other complications or concerns, etc. were elicited	40 days
Secondary	any other adverse events (complications)	determined if other complications occurred	40 days
Secondary	which side was more painful on or about postoperative day 21	determined which side was more painful on or about postoperative day 21 by asking patient and/or care giver	21 days
Secondary	overall assessment at the postoperative clinic visit (on or about day 28)	determined overall assessment at the postoperative clinic visit (on or about day 28) by asking patient and/or care giver	28 days