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

NCT02294162 | Withdrawn

• 1 other identifier: 0104-14
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Nasal Obstruction

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Readmission for any reason.

  one week

• Duration of hospital stay.

  one week

Study Arms (2)

0.5 mg/kg body weight Ketamin

EXPERIMENTAL

Patients allocated to this arm will receive an iv dose of 0.5 mg/kg body weight ketamine.

Drug: Ketamine i.v

5 ml normal saline as placebo

PLACEBO COMPARATOR

Patients allocated to this arm will receive an iv dose of 5ml saline as placebo.

Drug: Ketamine i.v

Interventions

Ketamine i.v DRUG

0.5 mg/kg body weight Ketamin; 5 ml normal saline as placebo

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Western Galilee Hospital-Nahariya: lead

Study Sites (1)

Galillee medical center

Nahariya, 2210001, Israel

Location

MeSH Terms

Conditions

Nasal Obstruction

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Airway Obstruction; Respiratory Insufficiency; Respiration Disorders; Otorhinolaryngologic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD,

Study Record Dates

• First Submitted: November 14, 2014
• First Posted: November 19, 2014
• Study Start: April 1, 2015
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: October 3, 2018

Record last verified: 2018-10

Locations

IL (1)