Local Ketamine Instillation for Postoperative Analgesia

Assiut University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Postoperative Pain

Treatments: Drug: systemic administration of ketamine; Drug: intra-wound instillation of normal saline; Drug: intra-wound instillation of ketamine

Study type: Interventional

Funder types: Other

Identifiers

NCT02642497

342

Details and patient eligibility

About

This study aims at exploring the analgesic efficacy, and safety of Ketamine instillation into the wound of total thyroidectomy compared to placebo,and to systemic ketamine administration (I.M. injection of the same dose) with respect to postoperative VAS, first request of analgesia, total opioid consumption, and with respect to possible side effects.

Enrollment: 90 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients with thyroid cancer scheduled for total thyroidectomy.

Exclusion criteria

1. BMI>35
2. Unstable ischaemic cardiac disease
3. Increased intracranial pressure
4. Increased intraocular pressure
5. Hypersensitivity or allergy to ketamine, local anesthetic, morphine, or other drugs used in the study.
6. Severe psychiatric disease
7. Unwillingness or inability to use PCA-device
8. Inability to use VAS scale

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

---

90 participants in 3 patient groups, including a placebo group

local ketamine group

Active Comparator group

Description:

intra-wound instillation of ketamine (1 mg/ kg) and normal saline in a total volume of 10 ml dispersed evenly throughout the wound; given after hemostasis and before wound closure, with closure of suction drain tube for 30 min. postoperatively.

Treatment:

Drug: intra-wound instillation of ketamine

control group

Placebo Comparator group

Description:

intra-wound instillation of normal saline in a total volume of 10 ml dispersed evenly throughout the wound; given after hemostasis and before wound closure, with closure of suction drain tube for 30 min. postoperatively.

Treatment:

Drug: intra-wound instillation of normal saline

systemic ketamine group

Active Comparator group

Description:

Intra-muscular injection of ketamine at a dose of 1 mg/kg before wound closure.

Treatment:

Drug: systemic administration of ketamine