Pain Relief for Submucosal Resection of Nasal Septum in Adults Does Ketamine Have a Pre-Emptive Effect?

Nasal Obstruction Clinical Trial

Official title:

Pain Relief for Submucosal Resection of Nasal Septum in Adults Does Ketamine Have a Pre-Emptive Effect?

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02294162
• Other study ID #: 0104-14
• Status: Withdrawn
• Phase: N/A
• Start date: April 1, 2015
• Est. completion date: October 1, 2017

Study information

• Verified date: October 2018
• Source: Western Galilee Hospital-Nahariya
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Pain is an unpleasant sensory experience associated with actual or potential tissue damage. Acute pain management is an important aspect of perioperative anesthetic care. Moreover, it is the most important factor related to patient discomfort after surgery. Adequate pain management, ideally resulting in the complete absence of postoperative pain, not only provides comfort to patients, but may also contribute to improved healing and a reduction in the incidence of postoperative complications. Inadequate postoperative analgesia has been shown to contribute to adverse outcomes, including, but not limited to, immunosuppression, hyperglycemia, poor rehabilitation, and progression to chronic pain.

Description:

Patients who are scheduled for submucosal resection of nasal septum with or without turbinectomy will be recruited for the study The patients will be will be assigned to either the treatment group who will be administered ketamine prior to the operation or the control group who will receive a normal saline injection, both in identicle syringes.

All patients will be operated on by the same surgoens and by the same method of dissection and hemostasis (2-5 2 ml lidocadrain carpules, monopolar suction-cautery set on 25).

Patients folow-up will be reported in their medical charts. The post operative analgetic effect will be assessed by the amount of analgesia required in the post-operative period and by regular pain measurements using VAS (Visual Analogue Scale) - at 0.5 hours post operation in the recovery room, 8 hours post operation and the morning of first post operative day in the otolaryngology - head and neck department

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 1, 2017
• Est. primary completion date: October 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Patients undergoing submucosal resection of nasal septum with or without turbinectomy.

• Over 18 years of age.

• ASA (anesthsiology Severity Score) score of 1-2.

• Signed informed consent by patient or caregiver.

Exclusion Criteria:

• Allergy to Ketamine

• Unable/ unwilling to comply with the protocol requirements

• Pregnancy or breast feeding

• Chronic use of analgetics

• History of alcohol and/or drug abuse

• Previous nasal surgry

Related Conditions & MeSH terms

• Nasal Obstruction

Intervention

Drug:
• Ketamine i.v

Locations

Country	Name	City	State
Israel	Galillee medical center	Naharia

Sponsors (1)

Lead Sponsor	Collaborator
Western Galilee Hospital-Nahariya

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain: reduction in severity based on VAS score.	The post operative analgetic effect will be assessed by the amount of analgesia required in the post-operative period and by regular pain measurements using VAS (Visual Analogue Scale) - at 0.5 hours post operation in the recovery room, 8 hours post operation and the morning of first post operative day	the morning of first post operative day
Primary	consumption of postoperative pain medication type, dosage and reduction in the demand postoperatively.	The data will be collected from the medical file	the morning of first post operative day
Secondary	Readmission for any reason.		one week
Secondary	Duration of hospital stay.		one week