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

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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02294162
Enrollment
0
Registered
2014-11-19
Start date
2015-04-01
Completion date
2017-10-01
Last updated
2018-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nasal Obstruction

Brief 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.

Detailed 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

Interventions

DRUGKetamine i.v

Sponsors

Western Galilee Hospital-Nahariya
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Pain: reduction in severity based on VAS score.the morning of first post operative dayThe 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
consumption of postoperative pain medication type, dosage and reduction in the demand postoperatively.the morning of first post operative dayThe data will be collected from the medical file

Secondary

MeasureTime frame
Readmission for any reason.one week
Duration of hospital stay.one week

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026